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.
Diagnocat
🇺🇸DGNCT, LLC
Analyzer, Medical Image
BIOGRAPH One
🇩🇪Siemens Healthineers AG
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
🇸🇪Elekta Solutions AB
Accelerator, Linear, Medical
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
🇮🇱Spectrum Dynamics Medical, Ltd.
System, Tomography, Computed, Emission
LOGIQ Totus
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
DS Core Detect
🇺🇸Dentsply Sirona, Inc.
Analyzer, Medical Image
BriefCase-Triage: CARE Multi-triage CT Body
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
LOGIQ Fortis
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
TruSPECT Processing Station
🇮🇱Spectrum Dynamics Medical, Ltd.
MR image reconstruction/enhancement
AIR Recon DL
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
ART-Plan+ (v3.1.0)
Therapanacea Sas
System, Planning, Radiation Therapy Treatment
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
BioticsAI
Bioticsai, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Lumify Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Alzevita
🇬🇧TOPIA MEDTECH LIMITED
MR image reconstruction/enhancement
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
🇩🇪Siemens Healthcare GmbH
System, Nuclear Magnetic Resonance Imaging
AI-CVD
🇺🇸HeartLung Corporation
MR image reconstruction/enhancement
MediAI-BA
Crescom Co., Ltd.
MR image reconstruction/enhancement
PVAD IQ Software
Ultrasight , Ltd.
MR image reconstruction/enhancement
UltraSight Guidance
Ultrasight , Ltd.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Neosoma Brain Mets
🇺🇸Neosoma, Inc.
MR image reconstruction/enhancement
IRISeg
🇺🇸Intuitive Surgical, Inc.
MR image reconstruction/enhancement
Swoop® Portable MR Imaging® System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
CogNet AI-MT+
🇺🇸Medcognetics, Inc.
Lesion detection/diagnosis software
Fetal EchoScan (v1.2)
🇫🇷Brightheart
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
ARTAssistant
🇨🇳Manteia Technologies Co., Ltd.
RT auto-contouring
Overjet CBCT Assist
Overjet, Inc.
MR image reconstruction/enhancement
AVIEW Lung Nodule CAD
🇰🇷Coreline Soft Co.,Ltd
Lung Computed Tomography System, Computer-Aided Detection
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
MR image reconstruction/enhancement
