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 the device name listed in this FDA 510(k) record. The listed applicant is Magnettx Oncology Solutions , Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) 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. The listed applicant is Magnettx Oncology Solutions , Ltd.. The 510(k) number is K213526.

When did Aurora-RT receive FDA 510(k) clearance?

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

Who is the listed applicant for Aurora-RT?

The FDA 510(k) record lists Magnettx Oncology Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora-RT?

The FDA product code for Aurora-RT is IYE.

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.