The following data is part of a premarket notification filed by Pronova Solutions, Llc with the FDA for Pronova Sc360 Proton Therapy System.
| Device ID | K162246 |
| 510k Number | K162246 |
| Device Name: | ProNova SC360 Proton Therapy System |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ProNova Solutions, LLC 330 Pellissippi Place Maryville, TN 37804 |
| Contact | Adam Kuhn |
| Correspondent | Adam Kuhn ProNova Solutions, LLC 330 Pellissippi Place Maryville, TN 37804 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2016-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863274000318 | K162246 | 000 |
| 00863274000301 | K162246 | 000 |