SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power

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 Definition Edge, Somatom Definition As/as+, Somatom Definition As Open, Somaton Emotion 6/16, Somatom Sensation 64/sensation Cardiac , Somatom Perspective Somatom Scope/ Scope Power.

Pre-market Notification Details

Device IDK142955
510k NumberK142955
Device Name:SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355
ContactKimberly Mangum
CorrespondentKimberly Mangum
SIEMENS MEDICAL SOLUTIONS 51 VALLEY STREAM PARKWAY Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-14
Decision Date2015-11-24
Summary:summary

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