b-box plus (DANAI)

Organization name

b-rayZ AG

SRN

CH-MF-000020036

Manufacturer status

Active

Primary placement in Germany; available across 13 countries total.

Trade name

not provided

UDI-DI code

07649991532027

Basic UDI-DI

7649991532bboxplus2xxEU

Reference / catalog number

b-box plus (DANAI)

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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 .

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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• Expiration date
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