FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
🇩🇪Brainlab AG
MR image reconstruction/enhancement
Ez3D-i /E3
🇰🇷Ewoosoft Co., Ltd
MR image reconstruction/enhancement
Biograph Vision.X and Biograph Vision.X Edge
🇺🇸Siemens Medical Solutions USA, Inc.
System, Tomography, Computed, Emission
Spine Auto Views
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
ECHELON Synergy MRI system
🇯🇵FUJIFILM Healthcare Corporation
System, Nuclear Magnetic Resonance Imaging
MOZI TPS
🇨🇳Manteia Technologies Co., Ltd.
System, Planning, Radiation Therapy Treatment
Spine CAMP (1.1)
🇺🇸Medical Metrics, Inc.
MR image reconstruction/enhancement
Axial3D Insight
🇬🇧Axial Medical Printing Limited
MR image reconstruction/enhancement
Bladder AI (AIBV01)
Exo Inc
MR image reconstruction/enhancement
HepaFatSmart (V2.0.0)
🇦🇺Resonance Health Analysis Services Pty Ltd
System, Nuclear Magnetic Resonance Imaging
Voluson SWIFT; Voluson SWIFT+
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
DeepCatch
MEDICALIP Co., Ltd
MR image reconstruction/enhancement
IB Lab LAMA
🇫🇷IB Lab GmbH
MR image reconstruction/enhancement
CAC Software
Imbio, Inc.
System, X-Ray, Tomography, Computed
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
🇧🇪FEops nv
MR image reconstruction/enhancement
Sonic DL
GE Medical Systems,LLC (GE Healthcare)
System, Nuclear Magnetic Resonance Imaging
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
🇺🇸Ge Medical Systems, LLC
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Genius AI Detection 2.0 with CC-MLO Correlation
🇺🇸Hologic, Inc.
Breast CAD (tomosynthesis)
Autoplaque
Cedars-Sinai Medical Center: AIM
System, Image Processing, Radiological
Radiation Planning Assistant (RPA)
🇺🇸University of Texas, MD Anderson Cancer Center
System, Planning, Radiation Therapy Treatment
EPIQ Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
SubtleMR (2.3.x)
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
Neurophet AQUA
🇰🇷Neurophet., Inc.
System, Image Processing, Radiological
Auto Segmentation
🇺🇸Ge Medical Systems, LLC
RT auto-contouring
Lumify Diagnostic Ultrasound System
🇺🇸Philips Ultrasound
System, Imaging, Pulsed Doppler, Ultrasonic
SIS System
Surgical Information Sciences, Inc.
MR image reconstruction/enhancement
Precision DL
🇺🇸GE Healthcare
System, Tomography, Computed, Emission
MR DWI/FLAIR Measurement V1.0
🇫🇷Olea Medical
System, Image Processing, Radiological
iCAC Device
Bunkerhill, Inc
System, X-Ray, Tomography, Computed
Ceevra Reveal 3
🇺🇸Ceevra, Inc.
MR image reconstruction/enhancement
