M-Vu Algorithm Engine - The M-Vu Algorithm Engine is a Computer-Aided - VUCOMP, INC.

Duns Number:145991621

Device Description: The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to 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.

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More Product Details

Catalog Number

-

Brand Name

M-Vu Algorithm Engine

Version/Model Number

1050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MYN

Product Code Name

Analyzer,Medical Image

Device Record Status

Public Device Record Key

912a0cc4-2c57-4f39-a9e1-6066fd2e077b

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

February 25, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VUCOMP, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1