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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K872150
Device Name I.S.G. 3DMV WORKSTATION
Applicant
I.S.G. Technologies, Inc.
3030 Orlando Dr. Mississauga
Ontario L4v 1s8,  CA
Applicant Contact IRENE GEARIN
Correspondent
I.S.G. Technologies, Inc.
3030 Orlando Dr. Mississauga
Ontario L4v 1s8,  CA
Correspondent Contact IRENE GEARIN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/04/1987
Decision Date 08/12/1987
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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