Cleared in 2023
Radiology AI devices with a 2023 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
BraveCX
Bering Ltd
Lesion detection/diagnosis software
MAGNETOM Free.Max; MAGNETOM Free.Star
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
Contour ProtégéAI
🇺🇸Mim Software, Inc.
RT auto-contouring
LOGIQ E10
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E10s, LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostic,
System, Imaging, Pulsed Doppler, Ultrasonic
Lunit INSIGHT DBT
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
aprevo® Digital Segmentation
🇺🇸Carlsmed, Inc.
MR image reconstruction/enhancement
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
🇺🇸Siemens Medical Solutions USA, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
MeVis Liver Suite
🇩🇪MeVis Medical Solutions AG
System, X-Ray, Tomography, Computed
SwiftMR
🇰🇷Airs Medical, Inc.
System, Image Processing, Radiological
Lumify Diagnostic Ultrasound System
🇺🇸Philips Ultrasound
System, Imaging, Pulsed Doppler, Ultrasonic
Rapid SDH
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
MR image reconstruction/enhancement
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Ultrasound System 1300
🇫🇷BK Medical Aps
System, Imaging, Pulsed Doppler, Ultrasonic
Sonix Health
🇰🇷Ontact Health Co., Ltd
MR image reconstruction/enhancement
Veuron-Brain-pAb3
🇰🇷Heuron Co., Ltd.
System, Image Processing, Radiological
SpotLight/SpotLight Duo (with DLIR option)
🇮🇱Arineta Ltd.
System, X-Ray, Tomography, Computed
NeuViz 128 Multi-Slice CT Scanner System
🇨🇳Neusoft Medical Systems Co., Ltd.
System, X-Ray, Tomography, Computed
Denti.AI Detect
🇨🇦Denti.AI Technology, Inc.
Analyzer, Medical Image
Swoop® Portable MR Imaging System®
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
cmAngio® V1.0
🇺🇸CureMetrix, Inc.
MR image reconstruction/enhancement
Clarius Ultrasound Scanner
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
DeepTek CXR Analyzer v1.0
🇮🇳DeepTek Medical Imaging Pvt Ltd
Analyzer, Medical Image
Momentum Spine
🇨🇦Momentum Health Inc.
Device, Sensing, Optical Contour
EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.Ai, Co., Ltd.
Triage & notification (CADt)
VUNO Med-DeepBrain
🇰🇷Vuno Inc.
MR image reconstruction/enhancement
