MULTIX Impact

System, X-ray, Stationary

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 Multix Impact.

Pre-market Notification Details

Device IDK193089
510k NumberK193089
Device Name:MULTIX Impact
ClassificationSystem, X-ray, Stationary
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-IA Malvern,  PA  19355
ContactMartin Rajchel
CorrespondentMartin Rajchel
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-IA Malvern,  PA  19355
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-06
Decision Date2020-03-20

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