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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 K183034
Device Name MOSAIQ Oncology Information System
Applicant
Elekta, Inc
100 Mathilda Place 5th Floor
Sunnyvale,  CA  94086
Applicant Contact Faiza Ahmed
Correspondent
Elekta, Inc
100 Mathilda Place 5th Floor
Sunnyvale,  CA  94086
Correspondent Contact Faiza Ahmed
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/01/2018
Decision Date 12/04/2018
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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