510(k) K162246
K162246 is an FDA 510(k) premarket notification submitted by Pronova Solutions, LLC for the device "ProNova SC360 Proton Therapy System". The FDA issued a decision of Substantially Equivalent on Dec 8, 2016. 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, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 2016
- Date Received
- Aug 10, 2016
- 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)