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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K896387
Device Name SXT-60F/60M MOBILE C ARM X-RAY UNIT
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact CHRISTOPHER M BOHL
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Correspondent Contact CHRISTOPHER M BOHL
Regulation Number892.1650
Classification Product Code
OXO  
Date Received11/06/1989
Decision Date 02/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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