ARCADIS AVANTIC

Image-intensified Fluoroscopic X-ray System, Mobile

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 Arcadis Avantic.

Pre-market Notification Details

Device IDK051133
510k NumberK051133
Device Name:ARCADIS AVANTIC
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern,  PA  19355
ContactMichael J Andrews
CorrespondentMichael J Andrews
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern,  PA  19355
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-03
Decision Date2005-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869009001 K051133 000

Trademark Results [ARCADIS AVANTIC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARCADIS AVANTIC
ARCADIS AVANTIC
79011364 3083079 Live/Registered
Siemens Healthcare GmbH
2005-05-06

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