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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 K190978
Device Name RefleXion Medical Radiotherapy System
Applicant
RefleXion Medical, Inc.
25841 Industrial Blvd, Suite 275
Hayward,  CA  94545
Applicant Contact Kathy O’Shaughnessy
Correspondent
RefleXion Medical, Inc.
25841 Industrial Blvd, Suite 275
Hayward,  CA  94545
Correspondent Contact Kathy O’Shaughnessy
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received04/15/2019
Decision Date 03/12/2020
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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