ARTIS Icono

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 Icono.

Pre-market Notification Details

Device IDK193326
510k NumberK193326
Device Name:ARTIS Icono
ClassificationInterventional Fluoroscopic X-ray System
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
ContactPatricia D. Jones
CorrespondentPatricia D. Jones
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern,  PA  19355
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
Subsequent Product CodeJAK
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-04-16

Trademark Results [ARTIS Icono]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTIS ICONO
ARTIS ICONO
79241116 5790693 Live/Registered
Siemens Healthcare GmbH
2018-08-07

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