MAMMOVISTA B.smart

System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammovista B.smart.

Pre-market Notification Details

Device IDK212621
510k NumberK212621
Device Name:MAMMOVISTA B.smart
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern,  PA  19355
ContactMartin Rajchel
CorrespondentMartin Rajchel
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern,  PA  19355
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-18
Decision Date2021-11-12

Trademark Results [MAMMOVISTA B.smart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAMMOVISTA B.SMART
MAMMOVISTA B.SMART
79317787 not registered Live/Pending
Siemens Healthcare GmbH
2021-06-18

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