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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 K001517
Device Name SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact MICHAEL FISHBACK
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1720
Classification Product Code
IZL  
Date Received05/16/2000
Decision Date 06/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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