SOMATOM SCOPE/SOMATOM 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 Scope/somatom Scope Power.

Pre-market Notification Details

Device IDK140912
510k NumberK140912
Device Name:SOMATOM SCOPE/SOMATOM SCOPE POWER
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactEve Davis
CorrespondentEve Davis
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 Received2014-04-09
Decision Date2014-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869013060 K140912 000
04056869013053 K140912 000
04056869010328 K140912 000
04056869010311 K140912 000

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