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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K953514
Device Name COURIER II
Applicant
Gammex, Inc.
2500 W. Beltline Hwy.
P.O. Box 620327
Middleton,  WI  53562
Applicant Contact THOMAS A DEMKE
Correspondent
Gammex, Inc.
2500 W. Beltline Hwy.
P.O. Box 620327
Middleton,  WI  53562
Correspondent Contact THOMAS A DEMKE
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/26/1995
Decision Date 10/07/1995
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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