M-Vu Algorithm Engine

GUDID M994MVU10500

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.

VUCOMP, INC.

Radiology DICOM image processing application software

• Primary Device ID: M994MVU10500
• NIH Device Record Key: 912a0cc4-2c57-4f39-a9e1-6066fd2e077b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Vu Algorithm Engine
• Version Model Number: 1050
• Company DUNS: 145991621
• Company Name: VUCOMP, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com
• Phone: 877-244-7707
• Email: support@vucomp.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M994MVU10500 [Primary]

FDA Product Code

• MYN: Analyzer,Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-12-04
• Device Publish Date: 2015-02-25