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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K063031
Device Name PRISM VIEW, MODEL
Applicant
Kyron Clinical Imaging, Inc.
2457 N. Mayfair Rd., Suite 202
Wauwatosa,  WI  53226
Applicant Contact JAMES L REUSS, PH.D.
Correspondent
Kyron Clinical Imaging, Inc.
2457 N. Mayfair Rd., Suite 202
Wauwatosa,  WI  53226
Correspondent Contact JAMES L REUSS, PH.D.
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/03/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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