385 results · 30ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·ONGUARD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·CLEAREAD DETECT

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK (TM)

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·M-VU ALGORITHM ENGINE

Caption Guidance

FDA 510(k)
FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)
FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)
FDA Class 2 ·Radiology

HeartFocus (V.1.1.1)

FDA 510(k)
FDA Class 2 ·Radiology

Cardiac Guidance

FDA 510(k)
FDA Class 2 ·Radiology

UltraSight AI Guidance

FDA 510(k)
FDA Class 2 ·Radiology