YSIO X.pree

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 Ysio X.pree.

Pre-market Notification Details

Device IDK201670
510k NumberK201670
Device Name:YSIO X.pree
ClassificationSystem, X-ray, Stationary
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern,  PA  19355
ContactAndrew Turner
CorrespondentAndrew Turner
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern,  PA  19355
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2020-10-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000
04056869232904 K201670 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.