SYNGO US WORKPLACE

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 Syngo Us Workplace.

Pre-market Notification Details

Device IDK091286
510k NumberK091286
Device Name:SYNGO US WORKPLACE
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View,  CA  94039 -7393
ContactShelly Pearce
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-05-01
Decision Date2009-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869003528 K091286 000

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