Detection (CADe)
Radiology AI devices in the Detection (CADe) category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.
US
HealthVCF
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
Multi-modalityDetection (CADe)510(k) 2020
US
AIMI-Triage CXR PTX
RADLogics, Inc.
Lesion detection/diagnosis software
Multi-modalityDetection (CADe)510(k) 2020
BreastUS
MammoScreen
🇺🇸Therapixel
Breast CAD (tomosynthesis)
Mammo / DBTDetection (CADe)510(k) 2020
BreastUS
Transpara
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
Mammo / DBTDetection (CADe)510(k) 2020
US
Red Dot
Behold.AI Technologies Limited
Lesion detection/diagnosis software
Multi-modalityDetection (CADe)510(k) 2020
BreastUS
Transpara
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
Mammo / DBTDetection (CADe)510(k) 2019
US
HealthCXR
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
Multi-modalityDetection (CADe)510(k) 2019
BreastUS
ProFound AI Software V2.1
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
Mammo / DBTDetection (CADe)510(k) 2019
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