Cios Select (VA21) Image Intensifier

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 Cios Select (va21) Image Intensifier.

Pre-market Notification Details

Device IDK210307
510k NumberK210307
Device Name:Cios Select (VA21) Image Intensifier
ClassificationInterventional Fluoroscopic X-ray System
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
ContactCordell Fields
CorrespondentCordell Fields
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-03-04

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