SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

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 Somatom Force, Somatom Definition Flash, Somatom Drive, Somatom Definition Edge, Somatom Definition As Open, Somatom Edge Plus, Somatom Definition As/as+, Somatom Confidence.

Pre-market Notification Details

Device IDK190578
510k NumberK190578
Device Name:SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern,  PA  19355
ContactKimberly Mangum
CorrespondentMaria Ebio
Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-06
Decision Date2019-06-27

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