510(k) K260597
K260597 is an FDA 510(k) premarket notification submitted by ProNova Solutions for the device "VIRTUE QA". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. ProNova Solutions has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2026
- Date Received
- Feb 24, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Charged-Particle, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)