Cleared in 2023
Radiology AI devices with a 2023 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
UltraSight AI Guidance
UltraSight Inc.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
OptimMRI
Rebrain, SAS
MR image reconstruction/enhancement
uOmnispace
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
syngo.CT Lung CAD (Version VD30)
🇩🇪Siemens Healthcare GmbH
Lung Computed Tomography System, Computer-Aided Detection
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
Lunit INSIGHT DBT
🇰🇷Lunit
Breast CAD (tomosynthesis)
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
