Syngo.CT Neuro Perfusion

System, X-ray, Tomography, Computed

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.ct Neuro Perfusion.

Pre-market Notification Details

Device IDK202213
510k NumberK202213
Device Name:Syngo.CT Neuro Perfusion
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 2501 N. Barrington Rd. Hoffman Estates,  IL  60192
ContactVeronica Padharia
CorrespondentVeronica Padharia
Siemens Medical Solutions USA, Inc. 2501 N. Barrington Rd. Hoffman Estates,  IL  60192
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2020-10-11

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