DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST

Table, Radiographic, Tilting

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 Dua-900a Image-intensified Fluoroscopic X-ray Syst.

Pre-market Notification Details

Device IDK922364
510k NumberK922364
Device Name:DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
ClassificationTable, Radiographic, Tilting
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactTimothy W Capehart
CorrespondentTimothy W Capehart
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
Product CodeIXR  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-19
Decision Date1992-09-04

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