RADREX-I, SW V4.00 MODEL DRAD-3000E

Solid State X-ray Imager (flat Panel/digital Imager)

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Radrex-i, Sw V4.00 Model Drad-3000e.

Pre-market Notification Details

Device IDK122842
510k NumberK122842
Device Name:RADREX-I, SW V4.00 MODEL DRAD-3000E
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin,  CA  92780
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin,  CA  92780
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-17
Decision Date2012-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670102196 K122842 000

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