Cleared in 2021
Radiology AI devices with a 2021 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
PowerLook Density Assessment V4.0
🇺🇸iCAD, Inc.
MR image reconstruction/enhancement
HALO
🇳🇱NICo-Lab B.V.
Triage & notification (CADt)
MAGNETOM Free.Max
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
RayStation 10.1
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
Precise Position
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTA
System, Image Processing, Radiological
syngo.via MI WorkFlows, Scenium, syngo MBF
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
🇺🇸Abbott Medical
System, Imaging, Optical Coherence Tomography (Oct)
Transpara 1.7.0
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
CINA CHEST
🇫🇷Avicenna.AI
Triage & notification (CADt)
Overjet Dental Assist
Overjet, Inc.
System, Image Processing, Radiological
SIGNA 7.0T
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
HS40 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Radformation AutoContour
🇺🇸Radformation
RT auto-contouring
HYPER AiR
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
Cartesion Prime (PCD-1000A/3) V10.8
🇯🇵Canon Medical Systems Corporation
System, Tomography, Computed, Emission
MEDO-Thyroid
MEDO DX Pte. Ltd.
MR image reconstruction/enhancement
Preview Shoulder
🇺🇸Genesis Software Innovations
MR image reconstruction/enhancement
Automatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLC
RT auto-contouring
AI Segmentation
🇺🇸Varian Medical Systems, Inc.
System, Planning, Radiation Therapy Treatment
Saige-Q
DeepHealth, Inc.
Lesion detection/diagnosis software
BriefCase, RIB Fractures Triage (RibFx)
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
DV. Target
Deepvoxel INC
RT auto-contouring
Eclipse II with Smart Noise Cancellation
🇺🇸Carestream Health, Inc.
Solid State X-Ray Imager (Flat Panel/Digital Imager)
SIS System (Version 5.1.0)
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
syngo.CT Lung CAD
🇩🇪Siemens Healthcare GmbH
Lung Computed Tomography System, Computer-Aided Detection
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Viz ICH
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
VBrain
Vysioneer Inc.
RT auto-contouring
