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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 K850417
Device Name INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
Applicant
Impact Systems Corp.
2448 S. 102nd.
Suite 325
Milwaukee,  WI  53227
Applicant Contact WILLIAM C MORTIMORE
Correspondent
Impact Systems Corp.
2448 S. 102nd.
Suite 325
Milwaukee,  WI  53227
Correspondent Contact WILLIAM C MORTIMORE
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/04/1985
Decision Date 10/16/1985
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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