Cleared in 2022
Radiology AI devices with a 2022 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
AVIEW
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.
System, Nuclear Magnetic Resonance Imaging
Philips CT 3500
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
Overjet Calculus Assist
Overjet, Inc.
Analyzer, Medical Image
BrainInsight
🇺🇸Hyperfine, Inc.
MR image reconstruction/enhancement
Saige-Density
DeepHealth, Inc.
MR image reconstruction/enhancement
Swoop Portable MR Imaging System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
BriefCase
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
Avenda Health AI Prostate Cancer Planning Software
🇺🇸Avenda Health, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
CINA
🇫🇷Avicenna.AI
Triage & notification (CADt)
SIS System (Version 5.6.0)
Surgical Information Sciences, Inc.
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
BoneMRI v1.4
MRlguidance B.V.
MR image reconstruction/enhancement
Syngo Dynamics (Version VA40F)
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
AVIEW RT ACS
🇰🇷Coreline Soft Co.,Ltd
RT auto-contouring
EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune.Ai, Co., Ltd.
Lesion detection/diagnosis software
uMR Omega with uWS-MR-MRS
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
EndoNaut
Therenva SAS
Interventional Fluoroscopic X-Ray System
Viz LVO ContaCT
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
AI-Rad Companion (Musculoskeletal)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
Spine CAMP
🇺🇸Medical Metrics, Inc.
MR image reconstruction/enhancement
AI-Rad Companion Organs RT
🇺🇸Siemens Medical Solutions USA, Inc.
RT auto-contouring
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Genius AI Detection 2.0
🇺🇸Hologic, Inc.
Breast CAD (tomosynthesis)
QIR Suite
CASIS Cardiac Simulation & Imaging Software
MR image reconstruction/enhancement
CogNet QmTRIAGE
🇺🇸Medcognetics, Inc.
Lesion detection/diagnosis software
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
NS-HGlio
🇺🇸Neosoma, Inc.
MR image reconstruction/enhancement
Aorta-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
