SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16

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 Emotion 6 Ct Systems, Somatom Emotion 16.

Pre-market Notification Details

Device IDK133424
510k NumberK133424
Device Name:SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-08
Decision Date2014-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869010298 K133424 000

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