Archive

Critical Care Suite with Enteric Tube Positioning AI Algorithm — Ge Medical Systems, LLC (FDA K253502)

Automates confirmation of enteric tube placement on X-rays, potentially reducing repeat imaging and aspiration risk in ICU patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 14 Apr

syngo Dynamics (VA41F) — Siemens Healthcare GmbH (FDA K253689)

This FDA-cleared AI tool can streamline your radiology workflow, potentially reducing reading time and improving diagnostic consistency in daily practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

TRIOS Dx (R1) — 3Shape TRIOS A/S (FDA K260082)

If you use intraoral scanners, this clearance signals AI diagnostics are entering routine dental workflows—expect caries or pathology flags on scans you already take.

Medicine · FDA — AI/ML-Enabled Medical Devices · 10 Apr

Relu Cloud — Relu BV (FDA K252708)

FDA-cleared AI cloud tool for radiology; check if it fits your workflow for faster, consistent reads.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

AI-Rad Companion Organs RT — Siemens Healthcare GmbH (FDA K252548)

This FDA-cleared AI tool automates organ segmentation for radiotherapy planning, potentially reducing contouring time and variability in your workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

DeepBT Detector-Plus — Aitewan Biomedical Technology, Inc. (FDA K252190)

This AI tool may help you detect breast tumors more accurately on imaging, potentially reducing missed lesions in your daily reads.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Apr

Seaman Pro/Seaman — Checkcells, Inc. (FDA K252228)

This FDA clearance signals a new AI hematology device entering the market; assess its validation before adopting in your lab.

Medicine · FDA — AI/ML-Enabled Medical Devices · 9 Apr

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) — Anumana, Inc. (FDA K253801)

This AI ECG algorithm flags cardiac amyloidosis earlier from a routine 12-lead, enabling timely diagnosis and treatment in a condition often missed.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 7 Apr

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) — Esaote, S.p.A. (FDA K253288)

New Esaote ultrasound systems cleared for radiology use; consider if upgrading your department's imaging capabilities for better diagnostic confidence.

Radiology · FDA — AI/ML-Enabled Medical Devices · 6 Apr

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) — Shanghai United Imaging Healthcare Co., Ltd. (FDA K260524)

New PET/CT scanner family cleared for US use; consider for high-throughput imaging with AI-assisted reconstruction, potentially improving throughput and image quality.

Radiology · FDA — AI/ML-Enabled Medical Devices · 3 Apr

MAGENTIQ-COLO (ME-APDS) — Magentiq Eye, Ltd. (FDA K260724)

An AI polyp-detection device cleared for colonoscopy could raise your adenoma detection rate and reduce missed lesions during routine screening.

Gastroenterology · FDA — AI/ML-Enabled Medical Devices · 3 Apr

CoLumbo C-Spine — Smart Soft Healthcare AD (FDA K254015)

AI tool cleared for C-spine imaging may speed fracture detection and reduce missed injuries in emergency radiology.

Radiology · FDA — AI/ML-Enabled Medical Devices · 1 Apr

AiORTA - Plan v2.0 — ViTAA Medical Solutions, Inc. (FDA K254207)

Automates aortic measurements for endovascular planning, potentially reducing manual error and turnaround time in CT angiography cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 30 Mar

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) — Anumana, Inc. (FDA K252360)

This AI ECG algorithm may help screen for pulmonary hypertension from a routine 12-lead, enabling earlier referral and diagnosis in primary care.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 28 Mar

Spectral CT Verida Family — Philips Medical Systems Technologies , Ltd. (FDA K253649)

Spectral CT gives you material decomposition on routine scans, improving tissue characterisation and reducing need for follow-up imaging in complex cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System — Philips Ultrasound, LLC (FDA K253595)

Philips ultrasound systems now cleared with AI features; if you use EPIQ or Affiniti, check which AI tools are enabled for your workflow.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

S-scan Open (100001800) — Esaote, S.p.A. (FDA K260746)

A new imaging device cleared for radiology use; check if it fits your workflow for better diagnostic access.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR — Canon Medical Systems Corporation (FDA K253625)

AiCE deep-learning reconstruction on 1.5T MR can shorten scan times or boost resolution; consider for faster throughput and clearer images in routine neuro/musculoskeletal work.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Butterfly Gestational Age Tool — Butterfly Network, Inc. (FDA K252148)

Enables point-of-care gestational age estimation on Butterfly ultrasound, potentially improving early pregnancy dating in low-resource settings.

Obstetrics & Gynaecology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Contour ProtégéAI+ — Mim Software, Inc. (FDA K253270)

AI auto-contouring can speed up radiotherapy planning, reducing manual delineation time and variability for your patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Automated Aortic Stenosis Software (AutoAS) — GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (FDA K254161)

AutoAS automates aortic stenosis grading on ultrasound, potentially reducing measurement variability and helping you triage valve disease faster in clinic.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Stealth AXiS Cranial clinical application — Medtronic Navigation, Inc. (FDA K253379)

New FDA-cleared navigation software for cranial procedures—check if your centre adopts it to improve intraoperative accuracy and workflow.

Neurology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

Lunit INSIGHT DBT (V1.2) — Lunit, Inc. (FDA K253796)

AI tool for digital breast tomosynthesis may help you detect cancers earlier and reduce recalls in screening.

Radiology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

SwiftMR — Airs Medical, Inc. (FDA K253775)

This AI speeds up MRI scans, cutting patient time and improving throughput—useful for busy Indian radiology practices.

Radiology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

Trinias — Shimadzu Corporation (FDA K252099)

This FDA clearance adds an AI-enabled imaging device option for radiology practices, potentially improving workflow or diagnostic accuracy in your department.

Medicine · FDA — AI/ML-Enabled Medical Devices · 24 Mar

JLK-NCCT — JLK, Inc. (FDA K252421)

This FDA-cleared AI tool may help you interpret non-contrast CTs faster, potentially reducing missed findings in urgent scans.

Radiology · FDA — AI/ML-Enabled Medical Devices · 24 Mar

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power — GE Medical Systems Ultrasound and Primary Care Diagnostics (FDA K260673)

Expands GE's AI-enabled ultrasound portfolio in India, offering clinicians validated imaging tools for faster, more consistent point-of-care diagnosis.

Radiology · FDA — AI/ML-Enabled Medical Devices · 24 Mar

True Definition DL — Ge Healthcare Japan Corporation (FDA K253686)

This FDA clearance signals another AI imaging tool entering practice; check if it fits your workflow before adopting.

Radiology · FDA — AI/ML-Enabled Medical Devices · 23 Mar

CT Rembra RT; CT Areta RT; CT Rembra — Philips Healthcare (Suzhou) Co., Ltd. (FDA K252992)

Philips' AI-based CT reconstruction may reduce radiation dose or improve image quality, affecting your scan protocols and patient safety.

Radiology · FDA — AI/ML-Enabled Medical Devices · 23 Mar

Photonova Spectra, Photonova Spectra Select — Ge Medical Systems, LLC (FDA K253520)

New GE imaging devices cleared for radiology—check if they improve workflow or image quality in your setting.

Radiology · FDA — AI/ML-Enabled Medical Devices · 20 Mar

SOMATOM X.cite; SOMATOM X.ceed — Siemens Medical Solutions USA, Inc. (FDA K253574)

New Siemens CT systems cleared for use; if you're in radiology, check if your facility's upgrade path includes these models for improved imaging.

Radiology · FDA — AI/ML-Enabled Medical Devices · 20 Mar

AutoContour (RADAC V5) — Radformation, Inc. (FDA K260509)

Auto-segmentation speeds contouring in radiotherapy planning, cutting manual work and variability—relevant if you plan or review radiation cases.

Radiology · FDA — AI/ML-Enabled Medical Devices · 19 Mar

syngo.via RT Image Suite VC10 — Varian Medical Systems, Inc. (FDA K252304)

This FDA clearance means you can now use this AI-enabled imaging suite for radiotherapy planning, potentially improving contouring accuracy and workflow efficiency in your department.

Radiology · FDA — AI/ML-Enabled Medical Devices · 18 Mar

Tyto Insights for Eardrum Bulging Detection — Tyto Care , Ltd. (FDA DEN250014)

This AI tool flags eardrum bulging from otoscopy images, aiding remote diagnosis of otitis media in primary care.

Medicine · FDA — AI/ML-Enabled Medical Devices · 17 Mar

EchoNavigator R5.0 — Philips Medical Systems Nederland B.V. (FDA K253614)

Philips' EchoNavigator R5.0 gains FDA clearance, aiding real-time fusion imaging during structural heart procedures—relevant for interventional radiologists and cardiologists in India.

Radiology · FDA — AI/ML-Enabled Medical Devices · 17 Mar

SurgiCount+ System — Stryker Instruments (FDA K252282)

Helps prevent retained surgical sponges with automated counting—reduces OR errors and patient harm.

General Surgery · FDA — AI/ML-Enabled Medical Devices · 16 Mar

Sonio Detect (v3) — Sonio (FDA K252433)

FDA-cleared AI for fetal ultrasound may streamline your scan workflow and flag anomalies earlier, but validate on your population.

Radiology · FDA — AI/ML-Enabled Medical Devices · 16 Mar

Data Analysis Facilitation Suite (DAFS) — Voronoi Health Analytics Incorporated (FDA K253944)

This FDA-cleared AI suite may streamline radiology data analysis, potentially reducing reporting time and aiding diagnostic workflows in your practice.

Radiology · FDA — AI/ML-Enabled Medical Devices · 16 Mar

InferCare RECIST — Beijing Infervision Healthcare Medical Technology Co., Ltd. (FDA K252261)

Automates RECIST tumor measurements on CT, saving radiologist time and improving consistency in oncology response assessment.

Radiology · FDA — AI/ML-Enabled Medical Devices · 13 Mar

Deep Capsule® (Deep Capsule US) — Digestaid - Artificial Intelligence Development SA (FDA K250655)

AI-assisted capsule endoscopy reading may reduce your review time and improve lesion detection in obscure GI bleeding.

Gastroenterology · FDA — AI/ML-Enabled Medical Devices · 12 Mar