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FDA 510(k)

OncoStudio (OS-01)

K-Number: K242994 · 2025-02-24

ApplicantOncosoft. Co., Ltd.
Decision Date2025-02-24
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OncoStudio (OS-01) is a medical device manufactured by Oncosoft. Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under approval number K242994. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OncoStudio (OS-01)?

OncoStudio (OS-01) is a medical device that received FDA 510(k) clearance on 2025-02-24. It is manufactured by Oncosoft. Co., Ltd.. The 510(k) number is K242994.

When was OncoStudio (OS-01) approved by the FDA?

OncoStudio (OS-01) received FDA 510(k) clearance on 2025-02-24, under approval number K242994.

What company makes OncoStudio (OS-01)?

OncoStudio (OS-01) is manufactured by Oncosoft. Co., Ltd..

What is the FDA product code for OncoStudio (OS-01)?

The FDA product code for OncoStudio (OS-01) is QKB.

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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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