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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, Photofluorographic
510(k) Number K920393
Device Name MU125M MOBILE X-RAY SYSTEM
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact DE MINT
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1730
Classification Product Code
IZG  
Date Received01/30/1992
Decision Date 04/06/1992
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
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