Syngo Dynamics (Version VA40E)

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 Dynamics (version Va40e).

Pre-market Notification Details

Device IDK220832
510k NumberK220832
Device Name:Syngo Dynamics (Version VA40E)
ClassificationSystem, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc. 400 W. Morgan Road Ann Arbor,  MI  48108
ContactAbhineet Johri
CorrespondentPrithul Bom
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 Received2022-03-22
Decision Date2022-05-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869287362 K220832 000

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