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FDA 510(k)

Aurora-RT

K-Number: K213526 · 2022-05-04

ApplicantMagnettx Oncology Solutions , Ltd.
Decision Date2022-05-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aurora-RT is a medical device manufactured by Magnettx Oncology Solutions , Ltd.. It received FDA 510(k) clearance on 2022-05-04 under approval number K213526. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aurora-RT?

Aurora-RT is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Magnettx Oncology Solutions , Ltd.. The 510(k) number is K213526.

When was Aurora-RT approved by the FDA?

Aurora-RT received FDA 510(k) clearance on 2022-05-04, under approval number K213526.

What company makes Aurora-RT?

Aurora-RT is manufactured by Magnettx Oncology Solutions , Ltd..

What is the FDA product code for Aurora-RT?

The FDA product code for Aurora-RT is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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