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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 K940294
Device Name SHIMADZU MOBILE X-RAY SYSTEMS
Applicant
Shimadzu Precision Instruments, Inc.
21010 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact MICHARL Y FISHBACK
Correspondent
Shimadzu Precision Instruments, Inc.
21010 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact MICHARL Y FISHBACK
Regulation Number892.1650
Classification Product Code
OXO  
Date Received01/21/1994
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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