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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 K943383
Device Name IMAGING WORKBENCH
Applicant
Brit Systems, Inc.
1909 Hi-Line Dr.,
Suite A
Dallas,  TX  75207
Applicant Contact KIM HERMAN
Correspondent
Brit Systems, Inc.
1909 Hi-Line Dr.,
Suite A
Dallas,  TX  75207
Correspondent Contact KIM HERMAN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/13/1994
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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