Cleared in 2025
Radiology AI devices with a 2025 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
JLK-SDH
🇰🇷JLK, Inc.
Triage & notification (CADt)
Myomics
Phantomics Inc.
MR image reconstruction/enhancement
ChestView US
Gleamer SAS
Analyzer, Medical Image
aiCockpit AI Viewer
🇺🇸Fovia, Inc.
System, Image Processing, Radiological
Ventripoint Medical System Plus (VMS+) 4.0
🇨🇦Ventripoint Diagnostics Ltd.
MR image reconstruction/enhancement
3DXR
🇫🇷GE Medical Systems SCS
Interventional Fluoroscopic X-Ray System
ART-Plan+ (v.3.0.0)
Therapanacea Sas
System, Planning, Radiation Therapy Treatment
OncoStudio (OS-01)
OncoSoft. Co., Ltd.
RT auto-contouring
QuickRad
Aikenist Technologies Pvt Ltd
System, Image Processing, Radiological
ScanDiags Ortho L-Spine MR-Q
ScanDiags AG
MR image reconstruction/enhancement
Sonio Suspect
🇨🇫Sonio
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.Ai, Co., Ltd.
Triage & notification (CADt)
CaRi-Plaque
Caristo Diagnostics Ltd.
System, Image Processing, Radiological
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Brainomix 360 e-ASPECTS
🇬🇧Brainomix Limited
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
AVIEW CAC
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
SubtleHD (1.x)
🇺🇸Subtle Medical, Inc.
MR image reconstruction/enhancement
Vivid T9/Vivid T8
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Vivid iq
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound Workspace (UWS 6.0)
🇺🇸Philips Ultrasound, LLC
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
BoneMetrics (US)
Gleamer SAS
MR image reconstruction/enhancement
Contour ProtégéAI+
🇺🇸Mim Software, Inc.
RT auto-contouring
Bunkerhill AVC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
TeraRecon Aorta.CT (1.1.0)
🇺🇸Terarecon,Inc.
MR image reconstruction/enhancement
Rapid Neuro3D
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
Prenuvo Body Composition
🇺🇸Prenuvo
System, Nuclear Magnetic Resonance Imaging
TechCare Trauma
🇫🇷Milvue
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
