{"slug": "q2-2026-ai-ml-fda-clearances-and-de-novos", "title": "Q2 2026 AI/ML FDA Clearances and De Novos", "summary": "The FDA cleared 14 AI/ML-enabled medical devices in Q2 2026, including De Novos and 510(k)s, spanning neurology, cardiology, radiology, and other specialties. Key clearances include neuropacs' MSAp/PSP classification tool, Anumana's ECG-based cardiac amyloidosis algorithm, and Siemens Healthineers' AI-Rad Companion Organs RT for automated segmentation.", "body_md": "| 2026-04-03 |\nneuropacs |\ndiffusion MRI data -> MSAp/PSP classification report -> neuroradiologists/neurologists differentiate Parkinsonian syndromes to guide clinical management |\n[DEN240071](https://fda.innolitics.com/device/DEN240071) |\nDe Novo |\nAutomated Imaging Diagnostics |\nNeurology |\nSHO |\nYes |\nNo |\n| 2026-04-03 |\nBlueprint Patient-Specific Instrumentation |\nDICOM CT scans -> 3D reconstruction, implant selection, and planning report -> surgeons perform precise shoulder arthroplasty/instability procedures |\n[K253674](https://fda.innolitics.com/device/K253674) |\n510(k) |\nStryker |\nOrthopedics |\nPHX |\nYes |\nNo |\n| 2026-04-03 |\nuMI Panvivo (uMI Panvivo LS) |\nPET radiopharmaceutical and CT attenuation data -> anatomical and functional PET/CT images -> physicians diagnose, stage, and plan radiotherapy |\n[K260524](https://fda.innolitics.com/device/K260524) |\n510(k) |\nUnited Imaging |\nRadiology |\nKPS |\nNo |\nNo |\n| 2026-04-03 |\nMAGENTIQ-COLO (ME-APDS) |\nColonoscopy video -> CADe polyp markers -> gastroenterologist targets lesion identification to improve mucosal detection rates |\n[K260724](https://fda.innolitics.com/device/K260724) |\n510(k) |\nMagentiq Eye, Ltd. |\nGastroenterology / Urology |\nQNP |\nYes |\nNo |\n| 2026-04-06 |\n6450 Ultrasound System (MyLabE80) |\nT2-weighted MRI and B-Mode ultrasound -> prostate gland segmentation -> clinician reviews contours to guide biopsy procedures |\n[K253288](https://fda.innolitics.com/device/K253288) |\n510(k) |\nEsaote, S.p.A. |\nRadiology |\nIYN |\nNo |\nNo |\n| 2026-04-07 |\nECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) |\n12-lead ECG voltage time series -> binary cardiac amyloidosis classification -> clinician identifies patients requiring further diagnostic workup |\n[K253801](https://fda.innolitics.com/device/K253801) |\n510(k) |\nAnumana |\nCardiovascular |\nSHP |\nYes |\nYes |\n| 2026-04-09 |\nSeaman Pro/Seaman |\nsemen sample video recordings -> quantitative sperm parameter report -> clinicians assess male fertility status |\n[K252228](https://fda.innolitics.com/device/K252228) |\n510(k) |\nCheckcells |\nHematology |\nPOV |\nNo |\nNo |\n| 2026-04-10 |\nDeepBT Detector-Plus |\nT1W+C and T2W MRI images -> automated GTV segmentation -> clinicians review/modify contours for radiation therapy planning |\n[K252190](https://fda.innolitics.com/device/K252190) |\n510(k) |\nAitewan Biomedical Technology |\nRadiology |\nQKB |\nYes |\nNo |\n| 2026-04-10 |\nAI-Rad Companion Organs RT |\nDICOM CT/MR images -> automated anatomical and brain metastases segmentation -> radiation oncologists expedite treatment planning workflows |\n[K252548](https://fda.innolitics.com/device/K252548) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nQKB |\nYes |\nNo |\n| 2026-04-10 |\nsyngo Dynamics (VA41F) |\nDICOM cardiac/vascular images -> AI-based quantification and view classification -> clinicians perform disease detection and patient management |\n[K253689](https://fda.innolitics.com/device/K253689) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nQIH |\nYes |\nYes |\n| 2026-04-10 |\nOverjet Iris Intelligent Imaging System |\n2D dental radiographs -> automated image quality advisory indicators -> clinicians optimize diagnostic image capture to minimize patient retakes |\n[K253930](https://fda.innolitics.com/device/K253930) |\n510(k) |\nOverjet |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-04-10 |\nTRIOS Dx (R1) |\n3D intraoral scans -> caries, wear, recession, and plaque quantification -> clinicians enhance patient communication and diagnostic accuracy |\n[K260082](https://fda.innolitics.com/device/K260082) |\n510(k) |\n3Shape TRIOS A/S |\nDental |\nSHQ |\nYes |\nNo |\n| 2026-04-14 |\nCritical Care Suite with Enteric Tube Positioning AI Algorithm |\nFrontal chest/abdominal X-ray images -> enteric tube/airway/diaphragm segmentation -> clinicians verify tube placement for patient safety |\n[K253502](https://fda.innolitics.com/device/K253502) |\n510(k) |\nGE HealthCare |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-04-17 |\nEdgeFlow UW20 |\nB-mode/harmonic ultrasound images -> automated bladder segmentation and volume measurement -> clinicians monitor bladder status to reduce manual scanning |\n[K252237](https://fda.innolitics.com/device/K252237) |\n510(k) |\nEdgecare |\nRadiology |\nIYO |\nNo |\nNo |\n| 2026-04-17 |\nNovasight Hybrid System |\nIVUS/OCT signals -> automated lumen/EEL/stent segmentation -> physician guides coronary interventions and assesses stent placement |\n[K252945](https://fda.innolitics.com/device/K252945) |\n510(k) |\nConavi Medical |\nCardiovascular |\nOBJ |\nNo |\nYes |\n| 2026-04-20 |\nFolliscan |\nTransvaginal ultrasound cine-loops -> follicle count and size quantification -> clinician verifies results to standardize ovulation monitoring |\n[K252332](https://fda.innolitics.com/device/K252332) |\n510(k) |\nMim Fertility |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-04-22 |\nEFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) |\nContrast-enhanced abdominal CT images -> text-based appendicitis triage alert -> clinician prioritizes review for earlier suspected case assessment |\n[K253163](https://fda.innolitics.com/device/K253163) |\n510(k) |\nEver [Fortune.Ai](http://fortune.ai/), Co., Ltd. |\nRadiology |\nQAS |\nYes |\nNo |\n| 2026-04-22 |\nmyosmart. (13E522) |\nSurface myoelectric signals -> prosthetic movement classification -> clinician calibrates personalized control for intuitive upper limb prosthetic function. |\n[K253256](https://fda.innolitics.com/device/K253256) |\n510(k) |\nOttobock |\nNeurology |\nGXY |\nNo |\nNo |\n| 2026-04-23 |\nLunit INSIGHT MMG (v1.1.10) |\nDICOM FFDM images -> CADe/x malignancy scores and heatmaps -> radiologist improves breast cancer detection accuracy |\n[K260320](https://fda.innolitics.com/device/K260320) |\n510(k) |\nLunit |\nRadiology |\nQDQ |\nYes |\nNo |\n| 2026-04-23 |\nDS Core CBCT Anatomy |\nCBCT and digital impression scans -> anatomical segmentation and registration -> dental professionals optimize diagnostic review and treatment planning |\n[K260785](https://fda.innolitics.com/device/K260785) |\n510(k) |\nDentsply Sirona |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-04-24 |\nOPTIS Mobile Next Imaging System (1014932) |\nOCT imaging and pressure wire inputs -> automated morphology assessment and physiological parameters -> physician determines coronary intervention necessity |\n[K253459](https://fda.innolitics.com/device/K253459) |\n510(k) |\nABBOTT MEDICAL |\nCardiovascular |\nNQQ |\nNo |\nNo |\n| 2026-04-27 |\nCASSIE |\nPPG and SpO2 waveforms -> sleep stage classification and respiratory indices -> clinicians diagnose sleep disorders to manage patient care |\n[K252628](https://fda.innolitics.com/device/K252628) |\n510(k) |\nWesper |\nAnesthesiology |\nMNR |\nYes |\nNo |\n| 2026-04-29 |\nDeepHealth ProstateAI |\nT2W, ADC, DWI MRI and prostate mask -> ROI segmentation and suspicion classification -> radiologist identifies prostate cancer lesions |\n[K253682](https://fda.innolitics.com/device/K253682) |\n510(k) |\nQuantib B.V. |\nRadiology |\nQDQ |\nYes |\nNo |\n| 2026-04-29 |\nsyngo Application Software |\nDICOM medical images -> 3D volumes, overlays, and navigation guidance -> physicians perform minimally invasive procedures with enhanced accuracy |\n[K254184](https://fda.innolitics.com/device/K254184) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nQIH |\nNo |\nNo |\n| 2026-04-30 |\nBayesian Health Sepsis Flagging Device |\n115 EHR parameters -> Sepsis Risk High triage alert -> HCPs facilitate timely sepsis intervention for adults |\n[K250680](https://fda.innolitics.com/device/K250680) |\n510(k) |\nBayesian Health |\nGastroenterology / Urology |\nSAK |\nYes |\nNo |\n| 2026-04-30 |\nIntelligent NR |\nFluoroscopic image data -> noise-reduced images/videos -> clinicians visualize anatomy more clearly to aid diagnostic decision-making |\n[K252503](https://fda.innolitics.com/device/K252503) |\n510(k) |\nCanon Medical |\nRadiology |\nOWB |\nYes |\nNo |\n| 2026-04-30 |\nSynapse 3D Base Tools (V7.2) |\nDICOM CT/MR images -> automated segmentation and quantitative measurements -> clinicians perform surgical planning and diagnostic reporting |\n[K254189](https://fda.innolitics.com/device/K254189) |\n510(k) |\nFujifilm |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-04 |\nMammoSightAI |\n2D FFDM and 3D DBT images -> 'Suspicious' triage alert -> radiologist prioritizes critical cases for earlier review |\n[K252954](https://fda.innolitics.com/device/K252954) |\n510(k) |\n[Savelife.ai](http://savelife.ai/) |\nRadiology |\nQFM |\nYes |\nNo |\n| 2026-05-04 |\nArteraAI Breast |\nH&E breast WSI + clinical variables -> 5/10-year distant metastasis risk score -> physician informs adjuvant therapy planning |\n[K254115](https://fda.innolitics.com/device/K254115) |\n510(k) |\nArtera |\nPathology |\nSHW |\nYes |\nYes |\n| 2026-05-05 |\nLumify Diagnostic Ultrasound System |\nAbdominal ultrasound video loops -> real-time anatomical CADe labeling -> clinicians perform faster, more accurate trauma assessments. |\n[K252558](https://fda.innolitics.com/device/K252558) |\n510(k) |\nPhilips |\nRadiology |\nIYN |\nYes |\nNo |\n| 2026-05-06 |\nBP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) |\nFingertip PPG, pressure, and accelerometer signals -> blood pressure measurement -> providers manage patient health via home spot-checks |\n[K253152](https://fda.innolitics.com/device/K253152) |\n510(k) |\nBiozen, LLC |\nCardiovascular |\nDXN |\nNo |\nYes |\n| 2026-05-07 |\nVeritas Reverse Total Shoulder System |\nPatient CT scans -> AI-segmented anatomical models -> surgeons design patient-specific implants to restore shoulder function |\n[K253992](https://fda.innolitics.com/device/K253992) |\n510(k) |\nRestor3D |\nOrthopedics |\nPHX |\nNo |\nNo |\n| 2026-05-08 |\nLingOral Dental Design System |\n3D mesh and DICOM images -> orthodontic/prosthetic CAD designs -> clinicians fabricate customized dental appliances for patient treatment |\n[K260419](https://fda.innolitics.com/device/K260419) |\n510(k) |\nHangzhou ChohoTech Co., Ltd. |\nDental |\nPNN |\nYes |\nNo |\n| 2026-05-11 |\nVelmeni for Dentists (V4D) Endo-Perio |\nDigital bitewing, periapical, and panoramic radiographs -> ML-driven segmentation and landmark detection -> dentists improve efficiency and accuracy in radiographic assessment. |\n[K252953](https://fda.innolitics.com/device/K252953) |\n510(k) |\nVelmeni |\nRadiology |\nMYN |\nYes |\nNo |\n| 2026-05-12 |\nRayvolve |\nMusculoskeletal X-ray images -> CADe/CADx fracture and effusion markers -> radiologists and emergency physicians improve diagnostic accuracy |\n[K260378](https://fda.innolitics.com/device/K260378) |\n510(k) |\nAZmed |\nRadiology |\nQBS |\nYes |\nNo |\n| 2026-05-13 |\nMorph |\n2D/3D T1-weighted MR images -> brain structure segmentation and volumetric quantification -> clinicians assess neurodegeneration in adult patients |\n[K260032](https://fda.innolitics.com/device/K260032) |\n510(k) |\nBeauBrain Healthcare |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-14 |\nSubtleHD-PET (1.x) |\nPET/CT or PET DICOM images -> noise-reduced PET images -> radiologists improve diagnostic confidence for patients undergoing PET imaging. |\n[K254013](https://fda.innolitics.com/device/K254013) |\n510(k) |\nSubtle Medical |\nRadiology |\nLLZ |\nYes |\nYes |\n| 2026-05-14 |\nBriefCase-Triage |\nHead CTA/mCTA DICOM images -> LVO and MeVO triage alert -> radiologist prioritizes time-sensitive critical cases |\n[K261317](https://fda.innolitics.com/device/K261317) |\n510(k) |\nAidoc |\nRadiology |\nQAS |\nYes |\nNo |\n| 2026-05-15 |\nNeurophet SCALE PET |\n3D T1-weighted MRI and PET scans -> SUVR and Centiloid quantification -> clinicians assess neurodegeneration and amyloid accumulation |\n[K252563](https://fda.innolitics.com/device/K252563) |\n510(k) |\nNeurophet. |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-15 |\nuSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super |\nUltrasound signals and images -> automated segmentation and biometry -> clinicians achieve standardized, efficient diagnostic workflows. |\n[K253716](https://fda.innolitics.com/device/K253716) |\n510(k) |\nUnited Imaging |\nRadiology |\nIYN |\nNo |\nNo |\n| 2026-05-15 |\nSubtleHD-CT (1.x) |\nDICOM CT images -> noise-reduced enhanced images -> radiologist reviews improved image quality for pediatric and adult patients |\n[K254120](https://fda.innolitics.com/device/K254120) |\n510(k) |\nSubtle Medical |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-15 |\nNeurophet AQUA |\n3D T1 and FLAIR MRI -> brain structure/lesion segmentation and volumetric quantification -> physician assesses neurodegenerative disease progression |\n[K261273](https://fda.innolitics.com/device/K261273) |\n510(k) |\nNeurophet. |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-20 |\nAquilion ONE (TSX-308A/TSX-306A) V2.0 |\nRaw X-ray volume data -> diagnostic cross-sectional images -> radiologist assesses anatomy and pathology for treatment planning. |\n[K253596](https://fda.innolitics.com/device/K253596) |\n510(k) |\nCanon Medical Systems |\nRadiology |\nJAK |\nNo |\nNo |\n| 2026-05-21 |\nDeepView AI® System |\nThermal burn optical images -> deep tissue segmentation and TBSA measurement -> physicians guide burn management and treatment planning |\n[DEN250028](https://fda.innolitics.com/device/DEN250028) |\nDe Novo |\nSpectralMD |\nSurgery |\nSHY |\nNo |\nNo |\n| 2026-05-21 |\nuSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite |\nultrasonic echoes -> automated cardiac/obstetric quantification -> clinicians improve diagnostic efficiency and measurement consistency for patient care |\n[K253720](https://fda.innolitics.com/device/K253720) |\n510(k) |\nUnited Imaging |\nRadiology |\nIYN |\nNo |\nNo |\n| 2026-05-21 |\nBAC |\nFFDM and DBT mammography images -> BAC presence classification and spatial localization -> physicians identify incidental calcifications to improve reporting accuracy |\n[K254131](https://fda.innolitics.com/device/K254131) |\n510(k) |\nDeepHealth |\nRadiology |\nQIH |\nYes |\nYes |\n| 2026-05-21 |\nMSK Go |\nB-mode ultrasound image streams -> anatomical segmentation and detection overlays -> clinicians enhance MSK ultrasound workflow efficiency |\n[K260234](https://fda.innolitics.com/device/K260234) |\n510(k) |\nSmart Alfa Teknoloji San. Ve Tic. A.S. |\nRadiology |\nQIH |\nYes |\nYes |\n| 2026-05-21 |\nStelo Glucose Biosensor System |\nInterstitial glucose measurements -> glucose values and metabolic insights -> users monitor lifestyle impacts without taking medical action |\n[K261359](https://fda.innolitics.com/device/K261359) |\n510(k) |\nDexcom |\nClinical chemistry |\nSAF |\nNo |\nNo |\n| 2026-05-22 |\nuMR Astra |\nMR signals and patient data -> diagnostic anatomical/functional images and quantifications -> physician diagnosis with reduced scan times |\n[K260113](https://fda.innolitics.com/device/K260113) |\n510(k) |\nUnited Imaging |\nRadiology |\nLNH |\nNo |\nNo |\n| 2026-05-22 |\nVitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning |\nCTA DICOM images -> automated segmentation and anatomical measurements -> cardiologists plan TAVR approach and device sizing |\n[K260324](https://fda.innolitics.com/device/K260324) |\n510(k) |\nCanon Medical Informatics |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-27 |\nVisby Medical Flu and COVID-19 Test |\nAnterior nasal swab sample -> qualitative classification of respiratory viral RNA -> lay user facilitates timely clinical follow-up |\n[K253971](https://fda.innolitics.com/device/K253971) |\n510(k) |\nVisby Medical |\nMicrobiology |\nSIA |\nYes |\nNo |\n| 2026-05-27 |\nSynapse Lung Nodule AI |\nNon-contrast chest CT images -> nodule detection, segmentation, and quantification -> radiologist improves diagnostic accuracy and reduces reading time |\n[K254075](https://fda.innolitics.com/device/K254075) |\n510(k) |\nFujifilm |\nRadiology |\nOEB |\nYes |\nNo |\n| 2026-05-27 |\nEPIQ Series Diagnostic Ultrasound Systems |\nUltrasound images of breast or thyroid lesions -> CADx diagnostic classification -> clinician assesses nodules to improve diagnostic accuracy |\n[K260680](https://fda.innolitics.com/device/K260680) |\n510(k) |\nPhilips |\nRadiology |\nIYN |\nNo |\nNo |\n| 2026-05-28 |\nANDI 2.2 |\nDiffusion-weighted and T1-weighted MRI -> brain structure volumetric quantification and reports -> neurologists inform clinical decision-making |\n[K261405](https://fda.innolitics.com/device/K261405) |\n510(k) |\nImeka Solutions |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-29 |\nZEUS Platform (FG0501US) |\nZio monitor ECG recordings -> annotated arrhythmia classification and reports -> clinicians diagnose cardiac events to manage patient symptoms |\n[K252859](https://fda.innolitics.com/device/K252859) |\n510(k) |\niRhythm Technologies |\nCardiovascular |\nDQK |\nYes |\nNo |\n| 2026-05-29 |\nHistoSonics® Planning Tool |\nCT/MRI DICOM images -> ML-based organ segmentation and 3D rendering -> physicians plan histotripsy procedures to reduce anesthetic time. |\n[K252947](https://fda.innolitics.com/device/K252947) |\n510(k) |\nHistoSonics |\nRadiology |\nQTZ |\nYes |\nNo |\n| 2026-05-29 |\nOrthoGrid Hip AI® 4.0 |\n2D fluoroscopic images -> automated landmark/implant measurement -> surgeon optimizes THA component positioning for improved surgical precision. |\n[K260077](https://fda.innolitics.com/device/K260077) |\n510(k) |\nOrthoGrid Systems |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-05-29 |\nGI Genius™ Module 300 (GGM300-US) |\nLive white-light endoscopic video -> CADe polyp markers -> endoscopist improves real-time detection of colonic lesions during screening |\n[K261369](https://fda.innolitics.com/device/K261369) |\n510(k) |\nCosmo AI |\nGastroenterology / Urology |\nQNP |\nNo |\nNo |\n| 2026-06-02 |\nTyto Insights for Wheeze Detection (with PCCP) |\n6-12 second lung audio files -> wheeze binary classification -> clinician interprets result alongside patient data for assessment |\n[K252844](https://fda.innolitics.com/device/K252844) |\n510(k) |\nTytoCare |\nAnesthesiology |\nPHZ |\nYes |\nYes |\n| 2026-06-03 |\nHeartFocus |\nReal-time ultrasound stream -> acquisition-quality guidance and auto-capture -> clinician standardizes 2D-TTE views for diagnostic review |\n[K260780](https://fda.innolitics.com/device/K260780) |\n510(k) |\nDESKi |\nRadiology |\nQJU |\nYes |\nYes |\n| 2026-06-04 |\nInstrument Exit Point on Touch Surgery™ Aide |\nLive endoscopic video -> instrument exit prediction/last-seen overlay -> surgeon locates instruments to improve procedural efficiency and safety |\n[K253984](https://fda.innolitics.com/device/K253984) |\n510(k) |\nMedtronic |\nSurgery |\nSFE |\nYes |\nNo |\n| 2026-06-04 |\nDEEPVESSEL Plaque |\nCCTA DICOM images -> coronary plaque/stenosis quantification reports -> clinicians assess coronary anatomy to guide treatment paths |\n[K260497](https://fda.innolitics.com/device/K260497) |\n510(k) |\nKeya Medical |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-04 |\nSonio Suspect |\nFetal ultrasound images -> CADe/CADx abnormal findings -> clinician identifies fetal anomalies to guide patient management |\n[K261519](https://fda.innolitics.com/device/K261519) |\n510(k) |\nSonio |\nRadiology |\nPOK |\nYes |\nNo |\n| 2026-06-05 |\nEyeBOX SNAP |\nEye-tracking metrics and symptom severity -> SNAP Score classification -> clinician aids concussion diagnosis for patients 15-25 |\n[K254086](https://fda.innolitics.com/device/K254086) |\n510(k) |\nOculogica |\nNeurology |\nQEA |\nNo |\nNo |\n| 2026-06-08 |\nEchoNext |\n12-lead ECG waveforms and demographics -> SHD and sub-label classification -> clinicians identify patients requiring further structural heart disease follow-up |\n[K260332](https://fda.innolitics.com/device/K260332) |\n510(k) |\nPathway Labs |\nCardiovascular |\nQXO |\nYes |\nNo |\n| 2026-06-09 |\nES-Series |\nTransabdominal ultrasound raw data -> liver/spleen stiffness and HDFF quantification -> clinicians manage adult liver steatosis and disease |\n[K260748](https://fda.innolitics.com/device/K260748) |\n510(k) |\nE-Scopics |\nRadiology |\nIYN |\nYes |\nNo |\n| 2026-06-10 |\nDeepXray Spina |\nFrontal lumbar spine or KUB radiographs -> binary BMD classification report -> radiologist prompts clinical bone health assessment |\n[K253192](https://fda.innolitics.com/device/K253192) |\n510(k) |\nAlpha Intelligence Manifolds |\nRadiology |\nSAO |\nYes |\nNo |\n| 2026-06-12 |\nBrainomix 360 Hyperdensity |\nNCCT head scans -> intracranial hyperdensity segmentation and volumetric quantification -> physician reviews findings to expedite acute hemorrhage diagnostic workup |\n[K260406](https://fda.innolitics.com/device/K260406) |\n510(k) |\nBrainomix |\nRadiology |\nQIH |\nYes |\nYes |\n| 2026-06-15 |\nMediAI-OA |\nDICOM knee X-rays -> KL grade and OA feature classification -> clinicians assess degenerative arthritis status |\n[K253172](https://fda.innolitics.com/device/K253172) |\n510(k) |\nCrescom |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-15 |\nLungMaps |\n2D lung MR time series -> lung segmentation, perfusion/ventilation maps, and statistics -> radiologist assists lung function diagnosis |\n[K253690](https://fda.innolitics.com/device/K253690) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-15 |\nSaige-Dx |\nDBT and 2D mammography images -> CADe/CADx suspicion levels and reports -> radiologist identifies lesions to improve screening accuracy |\n[K253825](https://fda.innolitics.com/device/K253825) |\n510(k) |\nDeepHealth |\nRadiology |\nQDQ |\nYes |\nNo |\n| 2026-06-15 |\nWatchMate Software |\n2D TEE video inputs -> 3D mesh and landing zone measurements -> clinicians size LAAC devices to improve procedural planning |\n[K260300](https://fda.innolitics.com/device/K260300) |\n510(k) |\nAnumana |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-16 |\nACUSON Sequoia Diagnostic Ultrasound System |\nUltrasound echo data -> AI-based valve/chamber quantification and hepatic steatosis index -> physicians guide clinical diagnosis and management |\n[K260844](https://fda.innolitics.com/device/K260844) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nIYN |\nNo |\nNo |\n| 2026-06-18 |\nRadOncAI |\nCT scans and RT structure sets -> 3D dose distribution prediction -> clinicians optimize head and neck treatment plans |\n[K253050](https://fda.innolitics.com/device/K253050) |\n510(k) |\nInformai |\nRadiology |\nMUJ |\nYes |\nNo |\n| 2026-06-18 |\nARTHUR |\nPatient hand anatomy and ultrasound signals -> automated joint image capture -> clinician reviews musculoskeletal images for diagnosis |\n[K260190](https://fda.innolitics.com/device/K260190) |\n510(k) |\nROPCA |\nRadiology |\nIYO |\nNo |\nNo |\n| 2026-06-18 |\nVascular Assist Occlusion Triage (VAOT) (v1.0) |\nCTA images -> triage alert for arterial occlusion -> radiologist prioritizes reading queue to improve workflow efficiency |\n[K260729](https://fda.innolitics.com/device/K260729) |\n510(k) |\nGuideAI Health |\nRadiology |\nQAS |\nYes |\nNo |\n| 2026-06-18 |\nSynapse PACS (7.6.0) |\nDICOM/non-DICOM medical images -> automated segmentation, quantification, and structured reports -> clinicians improve diagnostic workflow and treatment planning |\n[K261713](https://fda.innolitics.com/device/K261713) |\n510(k) |\nFujifilm |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-22 |\nRX-1 Sleep |\nECG, accelerometer, and SpO2 inputs -> AHI and sleep/wake classification report -> HCP diagnoses sleep apnea severity to guide patient treatment |\n[K253148](https://fda.innolitics.com/device/K253148) |\n510(k) |\nRhythm Express |\nAnesthesiology |\nMNR |\nYes |\nNo |\n| 2026-06-24 |\nEnhanced Boundary for PCCT |\nHead CT images -> soft tissue boundary enhancement -> radiologist improves diagnostic confidence in brain structure assessment |\n[K253560](https://fda.innolitics.com/device/K253560) |\n510(k) |\nGE HealthCare |\nRadiology |\nJAK |\nNo |\nNo |\n| 2026-06-24 |\nCeribell Neurology Review Software |\nEEG recordings -> artifact-reduced traces and epileptiform abnormality markers -> neurologists improve efficiency in clinical assessment |\n[K260998](https://fda.innolitics.com/device/K260998) |\n510(k) |\nCeribell |\nNeurology |\nOMB |\nYes |\nNo |\n| 2026-06-25 |\nsyngo.CT Coronary Cockpit |\nCCTA volume datasets -> coronary vessel segmentation and plaque quantification -> physicians confirm lesions and plan treatment |\n[K253786](https://fda.innolitics.com/device/K253786) |\n510(k) |\nSiemens Healthineers |\nRadiology |\nQIH |\nYes |\nYes |\n| 2026-06-26 |\nMammoScreen® (5) |\nFFDM and DBT mammography images -> CADe/CADx findings and suspicion scores -> radiologist improves screening interpretation accuracy |\n[K260714](https://fda.innolitics.com/device/K260714) |\n510(k) |\nTherapixel |\nRadiology |\nQDQ |\nYes |\nNo |\n| 2026-06-27 |\nSOMNUM (SOMNUM) |\nPSG physiological signals -> automated sleep stage/event classification -> clinicians diagnose sleep disorders with improved efficiency |\n[K253390](https://fda.innolitics.com/device/K253390) |\n510(k) |\nHoneyNaps |\nNeurology |\nOLZ |\nYes |\nNo |\n| 2026-06-29 |\nAuto-Seg (SO-0012), Spine Auto-Seg (SO-0012) |\nCT DICOM images -> 3D vertebrae and pelvis segmentation/labeling -> surgeons perform musculoskeletal assessment and surgical planning |\n[K253628](https://fda.innolitics.com/device/K253628) |\n510(k) |\nAgada Medical |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-29 |\nADAS 3D |\nDICOM MR and CTA images -> 3D cardiac segmentation and fibrosis quantification -> electrophysiologists plan cardiac procedures |\n[K253969](https://fda.innolitics.com/device/K253969) |\n510(k) |\nADAS 3D Medical |\nRadiology |\nQIH |\nYes |\nNo |\n| 2026-06-29 |\nAlturion Series Diagnostic Ultrasound System |\nUltrasound images (C5-1/C9-2) -> semi-automated kidney/spleen dimension measurements -> clinician reviews/adjusts measurements to improve workflow efficiency. |\n[K260667](https://fda.innolitics.com/device/K260667) |\n510(k) |\nPhilips |\nRadiology |\nIYN |\nNo |\nNo |", "url": "https://wpnews.pro/news/q2-2026-ai-ml-fda-clearances-and-de-novos", "canonical_source": "https://innolitics.com/articles/q-ai-ml-fda-clearances-and-de-novos/", "published_at": "2026-07-08 05:00:00+00:00", "updated_at": "2026-07-16 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