Q2 2026 AI/ML FDA Clearances and De Novos

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.

| 2026-04-03 | neuropacs | diffusion MRI data - MSAp/PSP classification report - neuroradiologists/neurologists differentiate Parkinsonian syndromes to guide clinical management | DEN240071 https://fda.innolitics.com/device/DEN240071 | De Novo | Automated Imaging Diagnostics | Neurology | SHO | Yes | No | | 2026-04-03 | Blueprint Patient-Specific Instrumentation | DICOM CT scans - 3D reconstruction, implant selection, and planning report - surgeons perform precise shoulder arthroplasty/instability procedures | K253674 https://fda.innolitics.com/device/K253674 | 510 k | Stryker | Orthopedics | PHX | Yes | No | | 2026-04-03 | uMI Panvivo uMI Panvivo LS | PET radiopharmaceutical and CT attenuation data - anatomical and functional PET/CT images - physicians diagnose, stage, and plan radiotherapy | K260524 https://fda.innolitics.com/device/K260524 | 510 k | United Imaging | Radiology | KPS | No | No | | 2026-04-03 | MAGENTIQ-COLO ME-APDS | Colonoscopy video - CADe polyp markers - gastroenterologist targets lesion identification to improve mucosal detection rates | K260724 https://fda.innolitics.com/device/K260724 | 510 k | Magentiq Eye, Ltd. | Gastroenterology / Urology | QNP | Yes | No | | 2026-04-06 | 6450 Ultrasound System MyLabE80 | T2-weighted MRI and B-Mode ultrasound - prostate gland segmentation - clinician reviews contours to guide biopsy procedures | K253288 https://fda.innolitics.com/device/K253288 | 510 k | Esaote, S.p.A. | Radiology | IYN | No | No | | 2026-04-07 | ECG-AI Cardiac Amyloidosis CA 12-Lead Algorithm 1040 | 12-lead ECG voltage time series - binary cardiac amyloidosis classification - clinician identifies patients requiring further diagnostic workup | K253801 https://fda.innolitics.com/device/K253801 | 510 k | Anumana | Cardiovascular | SHP | Yes | Yes | | 2026-04-09 | Seaman Pro/Seaman | semen sample video recordings - quantitative sperm parameter report - clinicians assess male fertility status | K252228 https://fda.innolitics.com/device/K252228 | 510 k | Checkcells | Hematology | POV | No | No | | 2026-04-10 | DeepBT Detector-Plus | T1W+C and T2W MRI images - automated GTV segmentation - clinicians review/modify contours for radiation therapy planning | K252190 https://fda.innolitics.com/device/K252190 | 510 k | Aitewan Biomedical Technology | Radiology | QKB | Yes | No | | 2026-04-10 | AI-Rad Companion Organs RT | DICOM CT/MR images - automated anatomical and brain metastases segmentation - radiation oncologists expedite treatment planning workflows | K252548 https://fda.innolitics.com/device/K252548 | 510 k | Siemens Healthineers | Radiology | QKB | Yes | No | | 2026-04-10 | syngo Dynamics VA41F | DICOM cardiac/vascular images - AI-based quantification and view classification - clinicians perform disease detection and patient management | K253689 https://fda.innolitics.com/device/K253689 | 510 k | Siemens Healthineers | Radiology | QIH | Yes | Yes | | 2026-04-10 | Overjet Iris Intelligent Imaging System | 2D dental radiographs - automated image quality advisory indicators - clinicians optimize diagnostic image capture to minimize patient retakes | K253930 https://fda.innolitics.com/device/K253930 | 510 k | Overjet | Radiology | QIH | Yes | No | | 2026-04-10 | TRIOS Dx R1 | 3D intraoral scans - caries, wear, recession, and plaque quantification - clinicians enhance patient communication and diagnostic accuracy | K260082 https://fda.innolitics.com/device/K260082 | 510 k | 3Shape TRIOS A/S | Dental | SHQ | Yes | No | | 2026-04-14 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Frontal chest/abdominal X-ray images - enteric tube/airway/diaphragm segmentation - clinicians verify tube placement for patient safety | K253502 https://fda.innolitics.com/device/K253502 | 510 k | GE HealthCare | Radiology | QIH | Yes | No | | 2026-04-17 | EdgeFlow UW20 | B-mode/harmonic ultrasound images - automated bladder segmentation and volume measurement - clinicians monitor bladder status to reduce manual scanning | K252237 https://fda.innolitics.com/device/K252237 | 510 k | Edgecare | Radiology | IYO | No | No | | 2026-04-17 | Novasight Hybrid System | IVUS/OCT signals - automated lumen/EEL/stent segmentation - physician guides coronary interventions and assesses stent placement | K252945 https://fda.innolitics.com/device/K252945 | 510 k | Conavi Medical | Cardiovascular | OBJ | No | Yes | | 2026-04-20 | Folliscan | Transvaginal ultrasound cine-loops - follicle count and size quantification - clinician verifies results to standardize ovulation monitoring | K252332 https://fda.innolitics.com/device/K252332 | 510 k | Mim Fertility | Radiology | QIH | Yes | No | | 2026-04-22 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM APPEN-CT-100 | Contrast-enhanced abdominal CT images - text-based appendicitis triage alert - clinician prioritizes review for earlier suspected case assessment | K253163 https://fda.innolitics.com/device/K253163 | 510 k | Ever Fortune.Ai http://fortune.ai/ , Co., Ltd. | Radiology | QAS | Yes | No | | 2026-04-22 | myosmart. 13E522 | Surface myoelectric signals - prosthetic movement classification - clinician calibrates personalized control for intuitive upper limb prosthetic function. | K253256 https://fda.innolitics.com/device/K253256 | 510 k | Ottobock | Neurology | GXY | No | No | | 2026-04-23 | Lunit INSIGHT MMG v1.1.10 | DICOM FFDM images - CADe/x malignancy scores and heatmaps - radiologist improves breast cancer detection accuracy | K260320 https://fda.innolitics.com/device/K260320 | 510 k | Lunit | Radiology | QDQ | Yes | No | | 2026-04-23 | DS Core CBCT Anatomy | CBCT and digital impression scans - anatomical segmentation and registration - dental professionals optimize diagnostic review and treatment planning | K260785 https://fda.innolitics.com/device/K260785 | 510 k | Dentsply Sirona | Radiology | QIH | Yes | No | | 2026-04-24 | OPTIS Mobile Next Imaging System 1014932 | OCT imaging and pressure wire inputs - automated morphology assessment and physiological parameters - physician determines coronary intervention necessity | K253459 https://fda.innolitics.com/device/K253459 | 510 k | ABBOTT MEDICAL | Cardiovascular | NQQ | No | No | | 2026-04-27 | CASSIE | PPG and SpO2 waveforms - sleep stage classification and respiratory indices - clinicians diagnose sleep disorders to manage patient care | K252628 https://fda.innolitics.com/device/K252628 | 510 k | Wesper | Anesthesiology | MNR | Yes | No | | 2026-04-29 | DeepHealth ProstateAI | T2W, ADC, DWI MRI and prostate mask - ROI segmentation and suspicion classification - radiologist identifies prostate cancer lesions | K253682 https://fda.innolitics.com/device/K253682 | 510 k | Quantib B.V. | Radiology | QDQ | Yes | No | | 2026-04-29 | syngo Application Software | DICOM medical images - 3D volumes, overlays, and navigation guidance - physicians perform minimally invasive procedures with enhanced accuracy | K254184 https://fda.innolitics.com/device/K254184 | 510 k | Siemens Healthineers | Radiology | QIH | No | No | | 2026-04-30 | Bayesian Health Sepsis Flagging Device | 115 EHR parameters - Sepsis Risk High triage alert - HCPs facilitate timely sepsis intervention for adults | K250680 https://fda.innolitics.com/device/K250680 | 510 k | Bayesian Health | Gastroenterology / Urology | SAK | Yes | No | | 2026-04-30 | Intelligent NR | Fluoroscopic image data - noise-reduced images/videos - clinicians visualize anatomy more clearly to aid diagnostic decision-making | K252503 https://fda.innolitics.com/device/K252503 | 510 k | Canon Medical | Radiology | OWB | Yes | No | | 2026-04-30 | Synapse 3D Base Tools V7.2 | DICOM CT/MR images - automated segmentation and quantitative measurements - clinicians perform surgical planning and diagnostic reporting | K254189 https://fda.innolitics.com/device/K254189 | 510 k | Fujifilm | Radiology | QIH | Yes | No | | 2026-05-04 | MammoSightAI | 2D FFDM and 3D DBT images - 'Suspicious' triage alert - radiologist prioritizes critical cases for earlier review | K252954 https://fda.innolitics.com/device/K252954 | 510 k | Savelife.ai http://savelife.ai/ | Radiology | QFM | Yes | No | | 2026-05-04 | ArteraAI Breast | H&E breast WSI + clinical variables - 5/10-year distant metastasis risk score - physician informs adjuvant therapy planning | K254115 https://fda.innolitics.com/device/K254115 | 510 k | Artera | Pathology | SHW | Yes | Yes | | 2026-05-05 | Lumify Diagnostic Ultrasound System | Abdominal ultrasound video loops - real-time anatomical CADe labeling - clinicians perform faster, more accurate trauma assessments. | K252558 https://fda.innolitics.com/device/K252558 | 510 k | Philips | Radiology | IYN | Yes | No | | 2026-05-06 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor BP1000 | Fingertip PPG, pressure, and accelerometer signals - blood pressure measurement - providers manage patient health via home spot-checks | K253152 https://fda.innolitics.com/device/K253152 | 510 k | Biozen, LLC | Cardiovascular | DXN | No | Yes | | 2026-05-07 | Veritas Reverse Total Shoulder System | Patient CT scans - AI-segmented anatomical models - surgeons design patient-specific implants to restore shoulder function | K253992 https://fda.innolitics.com/device/K253992 | 510 k | Restor3D | Orthopedics | PHX | No | No | | 2026-05-08 | LingOral Dental Design System | 3D mesh and DICOM images - orthodontic/prosthetic CAD designs - clinicians fabricate customized dental appliances for patient treatment | K260419 https://fda.innolitics.com/device/K260419 | 510 k | Hangzhou ChohoTech Co., Ltd. | Dental | PNN | Yes | No | | 2026-05-11 | Velmeni for Dentists V4D Endo-Perio | Digital bitewing, periapical, and panoramic radiographs - ML-driven segmentation and landmark detection - dentists improve efficiency and accuracy in radiographic assessment. | K252953 https://fda.innolitics.com/device/K252953 | 510 k | Velmeni | Radiology | MYN | Yes | No | | 2026-05-12 | Rayvolve | Musculoskeletal X-ray images - CADe/CADx fracture and effusion markers - radiologists and emergency physicians improve diagnostic accuracy | K260378 https://fda.innolitics.com/device/K260378 | 510 k | AZmed | Radiology | QBS | Yes | No | | 2026-05-13 | Morph | 2D/3D T1-weighted MR images - brain structure segmentation and volumetric quantification - clinicians assess neurodegeneration in adult patients | K260032 https://fda.innolitics.com/device/K260032 | 510 k | BeauBrain Healthcare | Radiology | QIH | Yes | No | | 2026-05-14 | SubtleHD-PET 1.x | PET/CT or PET DICOM images - noise-reduced PET images - radiologists improve diagnostic confidence for patients undergoing PET imaging. | K254013 https://fda.innolitics.com/device/K254013 | 510 k | Subtle Medical | Radiology | LLZ | Yes | Yes | | 2026-05-14 | BriefCase-Triage | Head CTA/mCTA DICOM images - LVO and MeVO triage alert - radiologist prioritizes time-sensitive critical cases | K261317 https://fda.innolitics.com/device/K261317 | 510 k | Aidoc | Radiology | QAS | Yes | No | | 2026-05-15 | Neurophet SCALE PET | 3D T1-weighted MRI and PET scans - SUVR and Centiloid quantification - clinicians assess neurodegeneration and amyloid accumulation | K252563 https://fda.innolitics.com/device/K252563 | 510 k | Neurophet. | Radiology | QIH | Yes | No | | 2026-05-15 | uSONIQUE 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 | Ultrasound signals and images - automated segmentation and biometry - clinicians achieve standardized, efficient diagnostic workflows. | K253716 https://fda.innolitics.com/device/K253716 | 510 k | United Imaging | Radiology | IYN | No | No | | 2026-05-15 | SubtleHD-CT 1.x | DICOM CT images - noise-reduced enhanced images - radiologist reviews improved image quality for pediatric and adult patients | K254120 https://fda.innolitics.com/device/K254120 | 510 k | Subtle Medical | Radiology | QIH | Yes | No | | 2026-05-15 | Neurophet AQUA | 3D T1 and FLAIR MRI - brain structure/lesion segmentation and volumetric quantification - physician assesses neurodegenerative disease progression | K261273 https://fda.innolitics.com/device/K261273 | 510 k | Neurophet. | Radiology | QIH | Yes | No | | 2026-05-20 | Aquilion ONE TSX-308A/TSX-306A V2.0 | Raw X-ray volume data - diagnostic cross-sectional images - radiologist assesses anatomy and pathology for treatment planning. | K253596 https://fda.innolitics.com/device/K253596 | 510 k | Canon Medical Systems | Radiology | JAK | No | No | | 2026-05-21 | DeepView AI® System | Thermal burn optical images - deep tissue segmentation and TBSA measurement - physicians guide burn management and treatment planning | DEN250028 https://fda.innolitics.com/device/DEN250028 | De Novo | SpectralMD | Surgery | SHY | No | No | | 2026-05-21 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | ultrasonic echoes - automated cardiac/obstetric quantification - clinicians improve diagnostic efficiency and measurement consistency for patient care | K253720 https://fda.innolitics.com/device/K253720 | 510 k | United Imaging | Radiology | IYN | No | No | | 2026-05-21 | BAC | FFDM and DBT mammography images - BAC presence classification and spatial localization - physicians identify incidental calcifications to improve reporting accuracy | K254131 https://fda.innolitics.com/device/K254131 | 510 k | DeepHealth | Radiology | QIH | Yes | Yes | | 2026-05-21 | MSK Go | B-mode ultrasound image streams - anatomical segmentation and detection overlays - clinicians enhance MSK ultrasound workflow efficiency | K260234 https://fda.innolitics.com/device/K260234 | 510 k | Smart Alfa Teknoloji San. Ve Tic. A.S. | Radiology | QIH | Yes | Yes | | 2026-05-21 | Stelo Glucose Biosensor System | Interstitial glucose measurements - glucose values and metabolic insights - users monitor lifestyle impacts without taking medical action | K261359 https://fda.innolitics.com/device/K261359 | 510 k | Dexcom | Clinical chemistry | SAF | No | No | | 2026-05-22 | uMR Astra | MR signals and patient data - diagnostic anatomical/functional images and quantifications - physician diagnosis with reduced scan times | K260113 https://fda.innolitics.com/device/K260113 | 510 k | United Imaging | Radiology | LNH | No | No | | 2026-05-22 | Vitrea CT Transcatheter Aortic Valve Replacement TAVR Planning | CTA DICOM images - automated segmentation and anatomical measurements - cardiologists plan TAVR approach and device sizing | K260324 https://fda.innolitics.com/device/K260324 | 510 k | Canon Medical Informatics | Radiology | QIH | Yes | No | | 2026-05-27 | Visby Medical Flu and COVID-19 Test | Anterior nasal swab sample - qualitative classification of respiratory viral RNA - lay user facilitates timely clinical follow-up | K253971 https://fda.innolitics.com/device/K253971 | 510 k | Visby Medical | Microbiology | SIA | Yes | No | | 2026-05-27 | Synapse Lung Nodule AI | Non-contrast chest CT images - nodule detection, segmentation, and quantification - radiologist improves diagnostic accuracy and reduces reading time | K254075 https://fda.innolitics.com/device/K254075 | 510 k | Fujifilm | Radiology | OEB | Yes | No | | 2026-05-27 | EPIQ Series Diagnostic Ultrasound Systems | Ultrasound images of breast or thyroid lesions - CADx diagnostic classification - clinician assesses nodules to improve diagnostic accuracy | K260680 https://fda.innolitics.com/device/K260680 | 510 k | Philips | Radiology | IYN | No | No | | 2026-05-28 | ANDI 2.2 | Diffusion-weighted and T1-weighted MRI - brain structure volumetric quantification and reports - neurologists inform clinical decision-making | K261405 https://fda.innolitics.com/device/K261405 | 510 k | Imeka Solutions | Radiology | QIH | Yes | No | | 2026-05-29 | ZEUS Platform FG0501US | Zio monitor ECG recordings - annotated arrhythmia classification and reports - clinicians diagnose cardiac events to manage patient symptoms | K252859 https://fda.innolitics.com/device/K252859 | 510 k | iRhythm Technologies | Cardiovascular | DQK | Yes | No | | 2026-05-29 | HistoSonics® Planning Tool | CT/MRI DICOM images - ML-based organ segmentation and 3D rendering - physicians plan histotripsy procedures to reduce anesthetic time. | K252947 https://fda.innolitics.com/device/K252947 | 510 k | HistoSonics | Radiology | QTZ | Yes | No | | 2026-05-29 | OrthoGrid Hip AI® 4.0 | 2D fluoroscopic images - automated landmark/implant measurement - surgeon optimizes THA component positioning for improved surgical precision. | K260077 https://fda.innolitics.com/device/K260077 | 510 k | OrthoGrid Systems | Radiology | QIH | Yes | No | | 2026-05-29 | GI Genius™ Module 300 GGM300-US | Live white-light endoscopic video - CADe polyp markers - endoscopist improves real-time detection of colonic lesions during screening | K261369 https://fda.innolitics.com/device/K261369 | 510 k | Cosmo AI | Gastroenterology / Urology | QNP | No | No | | 2026-06-02 | Tyto Insights for Wheeze Detection with PCCP | 6-12 second lung audio files - wheeze binary classification - clinician interprets result alongside patient data for assessment | K252844 https://fda.innolitics.com/device/K252844 | 510 k | TytoCare | Anesthesiology | PHZ | Yes | Yes | | 2026-06-03 | HeartFocus | Real-time ultrasound stream - acquisition-quality guidance and auto-capture - clinician standardizes 2D-TTE views for diagnostic review | K260780 https://fda.innolitics.com/device/K260780 | 510 k | DESKi | Radiology | QJU | Yes | Yes | | 2026-06-04 | Instrument Exit Point on Touch Surgery™ Aide | Live endoscopic video - instrument exit prediction/last-seen overlay - surgeon locates instruments to improve procedural efficiency and safety | K253984 https://fda.innolitics.com/device/K253984 | 510 k | Medtronic | Surgery | SFE | Yes | No | | 2026-06-04 | DEEPVESSEL Plaque | CCTA DICOM images - coronary plaque/stenosis quantification reports - clinicians assess coronary anatomy to guide treatment paths | K260497 https://fda.innolitics.com/device/K260497 | 510 k | Keya Medical | Radiology | QIH | Yes | No | | 2026-06-04 | Sonio Suspect | Fetal ultrasound images - CADe/CADx abnormal findings - clinician identifies fetal anomalies to guide patient management | K261519 https://fda.innolitics.com/device/K261519 | 510 k | Sonio | Radiology | POK | Yes | No | | 2026-06-05 | EyeBOX SNAP | Eye-tracking metrics and symptom severity - SNAP Score classification - clinician aids concussion diagnosis for patients 15-25 | K254086 https://fda.innolitics.com/device/K254086 | 510 k | Oculogica | Neurology | QEA | No | No | | 2026-06-08 | EchoNext | 12-lead ECG waveforms and demographics - SHD and sub-label classification - clinicians identify patients requiring further structural heart disease follow-up | K260332 https://fda.innolitics.com/device/K260332 | 510 k | Pathway Labs | Cardiovascular | QXO | Yes | No | | 2026-06-09 | ES-Series | Transabdominal ultrasound raw data - liver/spleen stiffness and HDFF quantification - clinicians manage adult liver steatosis and disease | K260748 https://fda.innolitics.com/device/K260748 | 510 k | E-Scopics | Radiology | IYN | Yes | No | | 2026-06-10 | DeepXray Spina | Frontal lumbar spine or KUB radiographs - binary BMD classification report - radiologist prompts clinical bone health assessment | K253192 https://fda.innolitics.com/device/K253192 | 510 k | Alpha Intelligence Manifolds | Radiology | SAO | Yes | No | | 2026-06-12 | Brainomix 360 Hyperdensity | NCCT head scans - intracranial hyperdensity segmentation and volumetric quantification - physician reviews findings to expedite acute hemorrhage diagnostic workup | K260406 https://fda.innolitics.com/device/K260406 | 510 k | Brainomix | Radiology | QIH | Yes | Yes | | 2026-06-15 | MediAI-OA | DICOM knee X-rays - KL grade and OA feature classification - clinicians assess degenerative arthritis status | K253172 https://fda.innolitics.com/device/K253172 | 510 k | Crescom | Radiology | QIH | Yes | No | | 2026-06-15 | LungMaps | 2D lung MR time series - lung segmentation, perfusion/ventilation maps, and statistics - radiologist assists lung function diagnosis | K253690 https://fda.innolitics.com/device/K253690 | 510 k | Siemens Healthineers | Radiology | QIH | Yes | No | | 2026-06-15 | Saige-Dx | DBT and 2D mammography images - CADe/CADx suspicion levels and reports - radiologist identifies lesions to improve screening accuracy | K253825 https://fda.innolitics.com/device/K253825 | 510 k | DeepHealth | Radiology | QDQ | Yes | No | | 2026-06-15 | WatchMate Software | 2D TEE video inputs - 3D mesh and landing zone measurements - clinicians size LAAC devices to improve procedural planning | K260300 https://fda.innolitics.com/device/K260300 | 510 k | Anumana | Radiology | QIH | Yes | No | | 2026-06-16 | ACUSON Sequoia Diagnostic Ultrasound System | Ultrasound echo data - AI-based valve/chamber quantification and hepatic steatosis index - physicians guide clinical diagnosis and management | K260844 https://fda.innolitics.com/device/K260844 | 510 k | Siemens Healthineers | Radiology | IYN | No | No | | 2026-06-18 | RadOncAI | CT scans and RT structure sets - 3D dose distribution prediction - clinicians optimize head and neck treatment plans | K253050 https://fda.innolitics.com/device/K253050 | 510 k | Informai | Radiology | MUJ | Yes | No | | 2026-06-18 | ARTHUR | Patient hand anatomy and ultrasound signals - automated joint image capture - clinician reviews musculoskeletal images for diagnosis | K260190 https://fda.innolitics.com/device/K260190 | 510 k | ROPCA | Radiology | IYO | No | No | | 2026-06-18 | Vascular Assist Occlusion Triage VAOT v1.0 | CTA images - triage alert for arterial occlusion - radiologist prioritizes reading queue to improve workflow efficiency | K260729 https://fda.innolitics.com/device/K260729 | 510 k | GuideAI Health | Radiology | QAS | Yes | No | | 2026-06-18 | Synapse PACS 7.6.0 | DICOM/non-DICOM medical images - automated segmentation, quantification, and structured reports - clinicians improve diagnostic workflow and treatment planning | K261713 https://fda.innolitics.com/device/K261713 | 510 k | Fujifilm | Radiology | QIH | Yes | No | | 2026-06-22 | RX-1 Sleep | ECG, accelerometer, and SpO2 inputs - AHI and sleep/wake classification report - HCP diagnoses sleep apnea severity to guide patient treatment | K253148 https://fda.innolitics.com/device/K253148 | 510 k | Rhythm Express | Anesthesiology | MNR | Yes | No | | 2026-06-24 | Enhanced Boundary for PCCT | Head CT images - soft tissue boundary enhancement - radiologist improves diagnostic confidence in brain structure assessment | K253560 https://fda.innolitics.com/device/K253560 | 510 k | GE HealthCare | Radiology | JAK | No | No | | 2026-06-24 | Ceribell Neurology Review Software | EEG recordings - artifact-reduced traces and epileptiform abnormality markers - neurologists improve efficiency in clinical assessment | K260998 https://fda.innolitics.com/device/K260998 | 510 k | Ceribell | Neurology | OMB | Yes | No | | 2026-06-25 | syngo.CT Coronary Cockpit | CCTA volume datasets - coronary vessel segmentation and plaque quantification - physicians confirm lesions and plan treatment | K253786 https://fda.innolitics.com/device/K253786 | 510 k | Siemens Healthineers | Radiology | QIH | Yes | Yes | | 2026-06-26 | MammoScreen® 5 | FFDM and DBT mammography images - CADe/CADx findings and suspicion scores - radiologist improves screening interpretation accuracy | K260714 https://fda.innolitics.com/device/K260714 | 510 k | Therapixel | Radiology | QDQ | Yes | No | | 2026-06-27 | SOMNUM SOMNUM | PSG physiological signals - automated sleep stage/event classification - clinicians diagnose sleep disorders with improved efficiency | K253390 https://fda.innolitics.com/device/K253390 | 510 k | HoneyNaps | Neurology | OLZ | Yes | No | | 2026-06-29 | Auto-Seg SO-0012 , Spine Auto-Seg SO-0012 | CT DICOM images - 3D vertebrae and pelvis segmentation/labeling - surgeons perform musculoskeletal assessment and surgical planning | K253628 https://fda.innolitics.com/device/K253628 | 510 k | Agada Medical | Radiology | QIH | Yes | No | | 2026-06-29 | ADAS 3D | DICOM MR and CTA images - 3D cardiac segmentation and fibrosis quantification - electrophysiologists plan cardiac procedures | K253969 https://fda.innolitics.com/device/K253969 | 510 k | ADAS 3D Medical | Radiology | QIH | Yes | No | | 2026-06-29 | Alturion Series Diagnostic Ultrasound System | Ultrasound images C5-1/C9-2 - semi-automated kidney/spleen dimension measurements - clinician reviews/adjusts measurements to improve workflow efficiency. | K260667 https://fda.innolitics.com/device/K260667 | 510 k | Philips | Radiology | IYN | No | No |