VIRTUE QA— 510(k) K260597
Substantially EquivalentProNova Solutions
FDA 510(k) clearance K260597 for VIRTUE QA, Substantially Equivalent on 2026-09-23. Applicant: ProNova Solutions. Device class: 2.
Summary
VIRTUE QA from ProNova Solutions is filed under LHN, charged-particle radiation therapy systems. "QA" in the name suggests a quality assurance product, but the record doesn't describe it.
Class II, 21 CFR 892.5050. The Radiology panel reviewed it as a Traditional 510(k).
ProNova filed from Maryville, Tennessee. Review took 211 days (February 24 to September 23, 2026).
Clearance details
- Applicant
- ProNova Solutions
- Product code
- Product code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maryville, TN, US
Recent devices under product code LHN
view allData sourced from openFDA. This site is unofficial and independent of the FDA.