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FDA 510(k)

MediAI-BA

K-Number: K250914 · 2025-12-18

ApplicantCrescom Co., Ltd.
Decision Date2025-12-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MediAI-BA is a medical device manufactured by Crescom Co., Ltd.. It received FDA 510(k) clearance on 2025-12-18 under approval number K250914. 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-BA?

MediAI-BA is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Crescom Co., Ltd.. The 510(k) number is K250914.

When was MediAI-BA approved by the FDA?

MediAI-BA received FDA 510(k) clearance on 2025-12-18, under approval number K250914.

What company makes MediAI-BA?

MediAI-BA is manufactured by Crescom Co., Ltd..

What is the FDA product code for MediAI-BA?

The FDA product code for MediAI-BA is QIH.

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Official Source

View on FDA Database →

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

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