FDA 510(k)

RadOncAI

K-Number: K253050 · 2026-06-18

Decision Date2026-06-18

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RadOncAI is the device name listed in this FDA 510(k) record. The listed applicant is Informai. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253050. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadOncAI?

RadOncAI is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Informai. The 510(k) number is K253050.

When did RadOncAI receive FDA 510(k) clearance?

RadOncAI received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253050.

Who is the listed applicant for RadOncAI?

The FDA 510(k) record lists Informai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadOncAI?

The FDA product code for RadOncAI is MUJ.

Related Devices (Code: MUJ)

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.