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.
AISAP Cardio V1.0
🇮🇱Aisap
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
CardIQ Suite
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
MammoScreen® (3)
🇺🇸Therapixel
Breast CAD (tomosynthesis)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
🇺🇸Siemens Medical Solutions USA, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Rayvolve
🇫🇷AZmed SAS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
MICSI-RMT
🇺🇸Microstructure Imaging, Inc.
System, Image Processing, Radiological
Swoop® Portable MR Imaging® System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
MR image reconstruction/enhancement
RUS
🇰🇷Hutom Inc.
MR image reconstruction/enhancement
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
SubtleSYNTH (1.x)
🇺🇸Subtle Medical, Inc.
MR image reconstruction/enhancement
SMART Bun-Yo-Matic X-Ray
Disior Ltd
MR image reconstruction/enhancement
Hyper Insight - ICH
🇰🇷SK Inc.
Triage & notification (CADt)
VEA Align; spineEOS
🇫🇷Eos Imaging
MR image reconstruction/enhancement
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
O-arm O2 Imaging System
🇺🇸Medtronic Navigation, Inc
Interventional Fluoroscopic X-Ray System
Medihub Prostate
🇰🇷JLK, Inc.
MR image reconstruction/enhancement
SMART Bun-Yo-Matic CT
Disior Ltd
MR image reconstruction/enhancement
SIS System
Surgical Information Sciences, Inc.
MR image reconstruction/enhancement
Clarius OB AI
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Radiography 7300 C
🇩🇪Philips Medical Systems DMC GmbH
System, X-Ray, Stationary
Relu Creator
🇧🇪Relu BV
MR image reconstruction/enhancement
RS85 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Cardiac CT Function Software Application
🇨🇦Circle Cardiovascular Imaging
MR image reconstruction/enhancement
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.Ai, Co., Ltd.
MR image reconstruction/enhancement
CINA-VCF
🇫🇷Avicenna.AI
Lesion detection/diagnosis software
uPMR 790
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
LVivo IQS
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Syngo Carbon Enterprise Access (VA40A)
🇩🇪Siemens Healthcare GmbH
System, Image Processing, Radiological
VinDr-Mammo
VinBigData Joint Stock Company
Lesion detection/diagnosis software
