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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
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.1980
Classification Product Code
IXR  
Date Received05/19/1992
Decision Date 09/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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