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.
syngo.CT LVO Detection
🇺🇸Siemens Medical Solutions USA, Inc.
Triage & notification (CADt)
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
cmAngio® (V1.6)
🇺🇸CureMetrix, Inc.
MR image reconstruction/enhancement
BunkerHill BMD
🇺🇸BunkerHill Health
Densitometer, Bone
HeartFocus (V.1.1.1)
🇫🇷Deski
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
QFR (3.0)
🇳🇱QFR Solutions bv
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
DeepFoqus (DeepFoqus-Accelerate)
Foqus Technologies Inc.
MR image reconstruction/enhancement
syngo Dynamics (Version VA41D)
🇩🇪Siemens Healthcare GmbH
MR image reconstruction/enhancement
Hi-D Imaging 4TAVR
Hi-D Imaging AG
MR image reconstruction/enhancement
MR Contour DL
🇺🇸GE Healthcare
RT auto-contouring
TribusConnect
TribusMed Beheer BV
MR image reconstruction/enhancement
AI-Rad Companion Organs RT
🇩🇪Siemens Healthcare GmbH
RT auto-contouring
Salix Central
Artrya Limited
MR image reconstruction/enhancement
V5med Lung AI
V5med Inc.
Lung Computed Tomography System, Computer-Aided Detection
Rayvolve LN
🇺🇸AZmed
Analyzer, Medical Image
Rayvolve PTX-PE
🇺🇸AZmed
Lesion detection/diagnosis software
Vent Creativity Knee v1.0 (Hermes)
🇺🇸Vent Creativity
MR image reconstruction/enhancement
brAIn Shoulder Positioning
🇺🇸Avatar Medical
System, Image Processing, Radiological
AVIEW
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
QP-Prostate® CAD
🇪🇸Quibim S.L.
Breast CAD (tomosynthesis)
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
SIGNA Prime Elite
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
Better Diagnostics Caries Assist (BDCA) Version 1.0
🇺🇸Better Diagnostics AI Corp
Analyzer, Medical Image
Cleerly LABS (v2.0)
🇺🇸Cleerly, Inc.
MR image reconstruction/enhancement
LVivo Seamless
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Prostate MR AI (VA10A)
🇩🇪Siemens Healthcare GmbH
Breast CAD (tomosynthesis)
Ceevra Reveal 3+
🇺🇸Ceevra, Inc.
MR image reconstruction/enhancement
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
