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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fludeoxyglucose F18-Guided Radiation Therapy System
510(k) Number K252071
Device Name RefleXion Medical Radiotherapy System, Reflexion X2
Applicant
Reflexion Medical, Inc.
25881 Industrial Blvd. Suite 275
Hayward,  CA  94545
Applicant Contact Leena Kadakia
Correspondent
Reflexion Medical, Inc.
25881 Industrial Blvd. Suite 275
Hayward,  CA  94545
Correspondent Contact Leena Kadakia
Classification Product Code
QVA  
Subsequent Product Codes
IYE   MUJ  
Date Received07/01/2025
Decision Date 12/18/2025
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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