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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 K123230
Device Name MOSAIQ ONCOLOGY INFORMATION SYSTEM
Applicant
IMPAC MEDICAL SYSTEMS, INC.
100 MATHILDA PLACE, 5TH FLOOR
SUNNYVALE,  CA  94086
Applicant Contact KATHRYN STINSON
Correspondent
IMPAC MEDICAL SYSTEMS, INC.
100 MATHILDA PLACE, 5TH FLOOR
SUNNYVALE,  CA  94086
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/15/2012
Decision Date 12/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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