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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 K972933
Device Name VOX/BASE FOR WINDOWS
Applicant
J-Mac System, Inc.
320 Fairway Dr.
Half Moon Bay,  CA  94019
Applicant Contact SHEILA W PICKERING
Correspondent
J-Mac System, Inc.
320 Fairway Dr.
Half Moon Bay,  CA  94019
Correspondent Contact SHEILA W PICKERING
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/08/1997
Decision Date 10/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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