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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, radiographic, tilting
510(k) Number K922364
Device Name DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 2068
Original Contact timothy w capehart
Regulation Number892.1980
Classification Product Code
IXR  
Date Received05/19/1992
Decision Date 09/04/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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