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.
PIUR tUS inside
🇦🇹PIUR Imaging GmbH
MR image reconstruction/enhancement
Synapse PACS (7.5)
🇺🇸FUJIFILM Healthcare Americas Corporation
MR image reconstruction/enhancement
EchoConfidence (USA)
Mycardium AI Limited
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
🇮🇹Esaote, S.p.A.
System, Imaging, Pulsed Doppler, Ultrasonic
CardIQ Suite
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
🇩🇪Brainlab AG
System, Planning, Radiation Therapy Treatment
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.
System, Nuclear Magnetic Resonance Imaging
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
🇩🇪Siemens Healthcare GmbH
System, Nuclear Magnetic Resonance Imaging
Methinks NCCT Stroke
Methinks Software S.L.
Triage & notification (CADt)
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
🇩🇪Brainlab AG
MR image reconstruction/enhancement
Second Opinion® CS
🇺🇸Pearl, Inc.
Analyzer, Medical Image
Aurora
🇮🇱GE Medical Systems Israel
System, Tomography, Computed, Emission
Viz Subdural+, Viz SUBDURAL PLUS
🇺🇸Viz.ai, Inc.
MR image reconstruction/enhancement
Cirrus Resting State fMRI Software
Sora Neuroscience, Inc.
MR image reconstruction/enhancement
BrightHeart View Classifier
🇫🇷Brightheart
MR image reconstruction/enhancement
Sonic DL
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
🇳🇱Philips Medical Systems Nederland B.V.
System, Nuclear Magnetic Resonance Imaging
TraumaCad Neo (1.1)
🇮🇱Brainlab Ltd.
MR image reconstruction/enhancement
AudaxCeph Cephalogram Analysis Software
Audax d.o.o.
MR image reconstruction/enhancement
Swoop® Portable MR Imaging® System (V2)
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
Opulus Lymphoma Precision
🇺🇸Roche Molecular Systems, Inc.
MR image reconstruction/enhancement
Allix5
🇺🇸Clairity, Inc.
Radiological Software Device To Predict Future Breast Cancer Risk
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Voluson Performance 16; Voluson Performance 18
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
CoLumboX
Smart Soft Healthcare AD
MR image reconstruction/enhancement
TAIMedImg DeepMets
Taiwan Medical Imaging Co., Ltd.
RT auto-contouring
Rapid MLS
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
Accuro 3S
🇺🇸Rivanna Medical, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
DEEPECHO
DeepEcho
System, Imaging, Pulsed Doppler, Ultrasonic
