Syngo.plaza

System, Image Processing, Radiological

Siemens Healthcare GmbH

The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.plaza.

Pre-market Notification Details

Device IDK180563
510k NumberK180563
Device Name:Syngo.plaza
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Healthcare GmbH Henkestrasse 127 Erlangen,  DE 91502
ContactVijay Ramadas
CorrespondentAlexander Schapovalov
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-03-05
Decision Date2018-04-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869096506 K180563 000

Trademark Results [Syngo.plaza]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNGO.PLAZA
SYNGO.PLAZA
79073973 3785042 Live/Registered
Siemens Healthcare GmbH
2009-06-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.