ARTIS ZEE/ZEEGO SW VC21

Interventional Fluoroscopic X-ray System

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 Artis Zee/zeego Sw Vc21.

Pre-market Notification Details

Device IDK141574
510k NumberK141574
Device Name:ARTIS ZEE/ZEEGO SW VC21
ClassificationInterventional Fluoroscopic X-ray System
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactPatricia D Jones
CorrespondentPatricia D Jones
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
Subsequent Product CodeJAK
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-12
Decision Date2014-09-05
Summary:summary

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