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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K943357
Device Name CEMAX SCANLINK V
Applicant
Cemax, Inc.
47281 Mission Falls Ct.
Fremont,  CA  94539
Applicant Contact DOUGLAS A MERK
Correspondent
Cemax, Inc.
47281 Mission Falls Ct.
Fremont,  CA  94539
Correspondent Contact DOUGLAS A MERK
Regulation Number892.2030
Classification Product Code
LMA  
Date Received07/12/1994
Decision Date 11/22/1994
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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