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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K895394
Device Name MOBILE X-RAY TELEVISION UNIT WHA-10A/B
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Applicant Contact MASAO YOSHIMURA
Correspondent
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Correspondent Contact MASAO YOSHIMURA
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/06/1989
Decision Date 11/13/1989
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
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