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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 K880169
Device Name CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
Applicant
Cemax, Inc.
1705 Wyatt Dr.
Santa Clara,  CA  95054
Applicant Contact EDWARD S ANDRLE
Correspondent
Cemax, Inc.
1705 Wyatt Dr.
Santa Clara,  CA  95054
Correspondent Contact EDWARD S ANDRLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/15/1988
Decision Date 03/09/1988
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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