M-Vu Algorithm Engine

Primary DI
M994MVU10500
Brand
M-Vu Algorithm Engine
Company
VUCOMP, INC.
Model
1050
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.
Published
2015-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYNAnalyzer,Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M994MVU10500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-244-7707support@vucomp.com

Regulatory Flags#

DUNS number
145991621
Device count
1
Serial number
true

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