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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 K941933
Device Name ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
Applicant
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Applicant Contact PETER R. G BAK
Correspondent
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Correspondent Contact PETER R. G BAK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/1994
Decision Date 07/29/1994
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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