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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Radiographic-Film
510(k) Number K970240
Device Name DIFFUSER PANEL
Applicant
Focused Viewer, Inc.
2420 Pasadena Blvd.
Wauwatosa,  WI  53226
Applicant Contact WILLIAM BRAUER, M.D.
Correspondent
Focused Viewer, Inc.
2420 Pasadena Blvd.
Wauwatosa,  WI  53226
Correspondent Contact WILLIAM BRAUER, M.D.
Regulation Number892.1890
Classification Product Code
IXC  
Date Received01/22/1997
Decision Date 03/11/1997
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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