VUCOMP, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer,Medical Image (MYN) (1)

Premarket Exempt

Clear

M-Vu Algorithm Engine - M994MVU10500 Catalog Number :

Device Description : The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device in The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to aid radiologists in reading mammograms. It is a proprietary software application designed to process digitized film mammograms and digital mammograms. The mammogram images are automatically analyzed to mark areas for review by a radiologist. Results are displayed on either a mammography workstation, high resolution monitor, or printed case report.

Device Class : 2

Duns Number: 145991621

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

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