FDA 510(k)

OncoStudio (OS-01)

K-Number: K242994 · 2025-02-24

Decision Date2025-02-24

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OncoStudio (OS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Oncosoft. Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) 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. The listed applicant is Oncosoft. Co., Ltd.. The 510(k) number is K242994.

When did OncoStudio (OS-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for OncoStudio (OS-01)?

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

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

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

Other records listing Oncosoft. 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.

K260528OncoStudio

Related Devices (Code: QKB)

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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.