AccessGUDID - DEVICE: M-Vu Algorithm Engine (M994MVU10500)

GUDID

Device Identifier (DI) Information

Brand Name: M-Vu Algorithm Engine
Version or Model: 1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VUCOMP, INC.

Primary DI Number: M994MVU10500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145991621 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYN	Analyzer,Medical Image

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 912a0cc4-2c57-4f39-a9e1-6066fd2e077b
Public Version Date: December 04, 2023
Public Version Number: 5
DI Record Publish Date: February 25, 2015