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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 K900967
Device Name MODIFIED ALPHA MC-9R C-ARM
Applicant
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact GERRY L BUSS
Correspondent
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact GERRY L BUSS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received03/02/1990
Decision Date 05/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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