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The Tracker / September 2026 / K260597

510(k) cleared

VIRTUE QA

ProNova Solutions · Sep 23, 2026 · K260597

FDA cleared the VIRTUE QA from ProNova Solutions on Sep 23, 2026 under K260597, a traditional 510(k). The device falls under product code LHN, System, Radiation Therapy, Charged-Particle, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 24, 2026. The decision came 211 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 ProNova Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260597?

K260597 is the FDA 510(k) for VIRTUE QA, submitted by ProNova Solutions. FDA's decision date was Sep 23, 2026, under product code LHN (System, Radiation Therapy, Charged-Particle, Medical).

Who makes the VIRTUE QA?

ProNova Solutions, based in Maryville, TN, is the applicant of record for K260597.

How long did the K260597 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Sep 23, 2026, 211 days later.

← All decisions in September 2026