Cleared in 2024
Radiology AI devices with a 2024 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
YSIO X.pree
🇩🇪Siemens Medical Solutions
System, X-Ray, Stationary
uOmnispace.CT
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
Heuron ICH
🇰🇷Heuron Co., Ltd.
Triage & notification (CADt)
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
SmartChest
🇫🇷Milvue
Lesion detection/diagnosis software
DeepContour (V1.0)
🇨🇳Wisdom Technologies., Inc.
RT auto-contouring
ECHELON Synergy V10.0
🇺🇸FUJIFILM Healthcare Americas Corporation
System, Nuclear Magnetic Resonance Imaging
CT 5300
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
🇺🇸Varian Medical Systems, Inc.
Accelerator, Linear, Medical
syngo.via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
Sonio Detect
🇨🇫Sonio
System, Imaging, Pulsed Doppler, Ultrasonic
uMR Jupiter
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
InVision Precision LVEF (LVEF)
InVision Medical Technology Corporation
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
ART-Plan (v.2.2.0)
Therapanacea Sas
System, Planning, Radiation Therapy Treatment
Rapid
iSchema View Inc.
System, Image Processing, Radiological
uOmnispace.MR
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
VisAble.IO
🇮🇱Techsomed
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
True Enhance DL
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
uMR 680
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Rho
🇨🇦16 Bit Inc
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.Ai, Co., Ltd.
Triage & notification (CADt)
Preview Shoulder
🇺🇸Genesis Software Innovations
MR image reconstruction/enhancement
AI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
RT auto-contouring
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Us2.v2
Eko.ai Pte. Ltd d/b/a Us2.ai
MR image reconstruction/enhancement
AVIEW CAC
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
NAEOTOM Alpha
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
