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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, Mobile
510(k) Number K955036
Device Name MOBILE X-RAY SYSTEM
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Applicant Contact HIROSHI ISHIHARA
Correspondent
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Correspondent Contact HIROSHI ISHIHARA
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/03/1995
Decision Date 12/22/1995
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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