MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

System, X-ray, Fluoroscopic, Image-intensified

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 Modular Angiography System Axiom Artis.

Pre-market Notification Details

Device IDK021021
510k NumberK021021
Device Name:MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin,  NJ  08830
ContactSandra Robinson
CorrespondentSandra Robinson
SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin,  NJ  08830
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-29
Decision Date2002-06-06
Summary:summary

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