8,962 results
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47ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Genius AI Detection 2.0
FDA 510(k)
FDA Class 2
·Radiology
Lunit INSIGHT DBT
FDA 510(k)
FDA Class 2
·Radiology
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
FDA 510(k)
FDA Class 2
·Cardiovascular
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
FDA 510(k)
FDA Class 2
·Cardiovascular
Prostate MR AI (VA10A)
FDA 510(k)
FDA Class 2
·Radiology
MammoScreen
FDA 510(k)
FDA Class 2
·Radiology
Lunit INSIGHT DBT v1.1
FDA 510(k)
FDA Class 2
·Radiology
PowerLook Tomo Detection V2 Software
FDA 510(k)
FDA Class 2
·Radiology
Transpara
FDA 510(k)
FDA Class 2
·Radiology
ProFound AI Software V3.0
FDA 510(k)
FDA Class 2
·Radiology
WavelinQ 4F EndoAVF System
FDA 510(k)
FDA Class 2
·Cardiovascular
ProFound Detection (V4.0)
FDA 510(k)
FDA Class 2
·Radiology
Ellipsys Vascular Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Transpara 1.7.0
FDA 510(k)
FDA Class 2
·Radiology
Transpara
FDA 510(k)
FDA Class 2
·Radiology
MammoScreen® (3)
FDA 510(k)
FDA Class 2
·Radiology
MammoScreen® (4)
FDA 510(k)
FDA Class 2
·Radiology
Genius AI Detection
FDA 510(k)
FDA Class 2
·Radiology
ProFound AI Software V2.1
FDA 510(k)
FDA Class 2
·Radiology
WavelinQ Plus EndoAVF System
FDA 510(k)
FDA Class 2
·Cardiovascular