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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, Stationary
510(k) Number K941931
Device Name DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Applicant Contact LINDA S MORIN
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Correspondent Contact LINDA S MORIN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/20/1994
Decision Date 05/26/1994
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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