RefleXion Medical Radiotherapy System

Accelerator, Linear, Medical

RefleXion Medical, Inc.

The following data is part of a premarket notification filed by Reflexion Medical, Inc. with the FDA for Reflexion Medical Radiotherapy System.

Pre-market Notification Details

Device IDK190978
510k NumberK190978
Device Name:RefleXion Medical Radiotherapy System
ClassificationAccelerator, Linear, Medical
Applicant RefleXion Medical, Inc. 25841 Industrial Blvd, Suite 275 Hayward,  CA  94545
ContactKathy O’shaughnessy
CorrespondentKathy O’shaughnessy
RefleXion Medical, Inc. 25841 Industrial Blvd, Suite 275 Hayward,  CA  94545
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-15
Decision Date2020-03-12

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