Eu Mdr
Eu Md Class 2a
On The Market
๐จ๐ญ Switzerland
MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
Devices (same UDI-DI)
1
Certificates
0
Countries
10
Notified Bodies
0
Basic Information
- Primary DI
- 07649991532027
- Basic UDI-DI Code
- 7649991532bboxplus2xxEU
- Reference
- b-box plus (DANAI)
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- b-rayZ AG
Additional Description
b-box plus (DANAI) is an AI stand-alone software indicated for the classification of mammographic breast density and pathological alterations according to the Breast Imaging-Reporting and Data System (BI-RADS) catalogue of the American College of Radiology , and for evaluation of diagnostic quality of digital mammograms according to the PGMI-method .
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
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