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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K883101
Device Name DVS (OPTION 01)
Applicant
O.M.I. Oncology Microsystems, Inc.
2232 Tashy Pl.
Victoria, B.C.
Canada,  CA V8N 4R6
Applicant Contact MORRIS, PH.D.
Correspondent
O.M.I. Oncology Microsystems, Inc.
2232 Tashy Pl.
Victoria, B.C.
Canada,  CA V8N 4R6
Correspondent Contact MORRIS, PH.D.
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/22/1988
Decision Date 10/07/1988
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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