SYNGO DUAL ENERGY SOFTWARE PACKAGE

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 Dual Energy Software Package.

Pre-market Notification Details

Device IDK132902
510k NumberK132902
Device Name:SYNGO DUAL ENERGY SOFTWARE PACKAGE
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactKimberly Mangum
CorrespondentKimberly Mangum
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-16
Decision Date2014-04-07
Summary:summary

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