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The Tracker / July 2026 / K260528

510(k) cleared

OncoStudio

Oncosoft. Inc., · Jul 2, 2026 · K260528

FDA cleared the OncoStudio from Oncosoft. Inc., on Jul 2, 2026 under K260528, a traditional 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Oncosoft. Inc., in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260528?

K260528 is the FDA 510(k) for OncoStudio, submitted by Oncosoft. Inc.,. FDA's decision date was Jul 2, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the OncoStudio?

Oncosoft. Inc.,, based in Seoul, is the applicant of record for K260528.

How long did the K260528 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jul 2, 2026, 135 days later.

← All decisions in July 2026