FDA 510(k)

MediAI-OA

K-Number: K253172 · 2026-06-15

Decision Date2026-06-15

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MediAI-OA is the device name listed in this FDA 510(k) record. The listed applicant is Crescom Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253172. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediAI-OA?

MediAI-OA is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Crescom Co., Ltd.. The 510(k) number is K253172.

When did MediAI-OA receive FDA 510(k) clearance?

MediAI-OA received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253172.

Who is the listed applicant for MediAI-OA?

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

What is the FDA product code for MediAI-OA?

The FDA product code for MediAI-OA is QIH.

Other records listing Crescom Co., Ltd. as applicant

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.