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.
Oncospace
Oncospace, Inc.
System, Planning, Radiation Therapy Treatment
ProFound AI Software V3.0
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
Imbio RV/LV Software
Imbio, LLC
MR image reconstruction/enhancement
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
🇬🇧Optellum Ltd
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
MaxFOV 2
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
SubtleMR
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
NinesMeasure
Nines, Inc.
System, Image Processing, Radiological
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
🇨🇦Perimeter Medical Imaging AI, Inc.
System, Imaging, Optical Coherence Tomography (Oct)
TruPlan
🇨🇦Circle Cardiovascular Imaging, Inc.
System, Image Processing, Radiological
Synapse 3D, Synapse 3D Base Tools v6.1
🇯🇵Fujifilm Corporation
System, Image Processing, Radiological
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
QUIBIM Precision Prostate (qp-Prostate)
🇪🇸Quibim S.L.
System, Image Processing, Radiological
Visage Breast Density
🇩🇪Visage Imaging GmbH
MR image reconstruction/enhancement
Vantage Orian 1.5T, MRT-1550, V6.0
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
uAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Lesion detection/diagnosis software
ART-Plan
🇫🇷TheraPanacea
RT auto-contouring
Hepatica v1 (Hepatica v1.0.0)
🇬🇧Perspectum, Ltd.
System, Nuclear Magnetic Resonance Imaging
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Imagio Breast Imaging System
🇺🇸Seno Medical Instruments, Inc.
Optoacoustic Imaging System
BrainInsight
Hyperfine Research, Inc
System, Image Processing, Radiological
