Aurora-RT

Accelerator, Linear, Medical

MagnetTx Oncology Solutions Ltd.

The following data is part of a premarket notification filed by Magnettx Oncology Solutions Ltd. with the FDA for Aurora-rt.

Pre-market Notification Details

Device IDK213526
510k NumberK213526
Device Name:Aurora-RT
ClassificationAccelerator, Linear, Medical
Applicant MagnetTx Oncology Solutions Ltd. 9505 41 Avenue NW Edmonton,  CA T6e 5x7
ContactMichael Cook
CorrespondentMichael Cook
MagnetTx Oncology Solutions Ltd. 9505 41 Avenue NW Edmonton,  CA T6e 5x7
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-04
Decision Date2022-05-04

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.