SOMATOM DEFINITION, MODEL AS/AS+

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 Definition, Model As/as+.

Pre-market Notification Details

Device IDK081022
510k NumberK081022
Device Name:SOMATOM DEFINITION, MODEL AS/AS+
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. E-50 Malvern,  PA  19355
ContactCorrine Mcleod
CorrespondentCorrine Mcleod
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. E-50 Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-10
Decision Date2008-06-02
Summary:summary

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