FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Vu Algorithm Engine
DI: M994MVU10500
·
Model: 1050
·
VUCOMP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M-Vu Algorithm Engine
- Primary DI
- M994MVU10500
- Version / Model
- 1050
- Company Name
- VUCOMP, INC.
- Labeler DUNS
- 145991621
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-25
- Public Version
- 5
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 912a0cc4-2c57-4f39-a9e1-6066fd2e077b
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYN | Analyzer,Medical Image | Radiology | 892.2070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M994MVU10500 | HIBCC |
Customer Contacts
- Phone
- 877-244-7707
- [email protected]