FDA 510(k)

OncoStudio

K-Number: K260528 · 2026-07-02

Decision Date2026-07-02

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OncoStudio is the device name listed in this FDA 510(k) record. The listed applicant is Oncosoft. Inc.,. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260528. 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?

OncoStudio is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Oncosoft. Inc.,. The 510(k) number is K260528.

When did OncoStudio receive FDA 510(k) clearance?

OncoStudio received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260528.

Who is the listed applicant for OncoStudio?

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

What is the FDA product code for OncoStudio?

The FDA product code for OncoStudio is QKB.

Other records listing Oncosoft. Inc., 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.

K242994OncoStudio (OS-01)

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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.