510(k) clearance

VIRTUE QA

FDA 510(k) source

510(k) number

K260597

Applicant

ProNova Solutions

Decision date

Sep 23, 2026

Date received

Feb 24, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LHN

Device type

System, Radiation Therapy, Charged-Particle, Medical

Device class

Class II

Regulation

21 CFR 892.5050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Maryville, TN, US