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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 K901679
Device Name RESUBMITTED ISG 3DMV WORKSTATION
Applicant
I.S.G. Technologies, Inc.
3030 Orlando Dr. Mississauga
Ontario L4v 1s8,  CA
Applicant Contact WILLIAM M WESTON,MD
Correspondent
I.S.G. Technologies, Inc.
3030 Orlando Dr. Mississauga
Ontario L4v 1s8,  CA
Correspondent Contact WILLIAM M WESTON,MD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/12/1990
Decision Date 05/29/1990
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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