The following data is part of a premarket notification filed by Mclaren Health Care Corporation with the FDA for Mclaren Proton Therapy System.
| Device ID | K160063 |
| 510k Number | K160063 |
| Device Name: | McLaren Proton Therapy System |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | McLaren Health Care Corporation G-3235 Beecher Rd., Suite B Flint, MI 48532 |
| Contact | Ryan Vlcko |
| Correspondent | Daniel Gottlieb Epstein Becker & Green, P.C. 1227 25th St. NW Ste. 700 Washington, DC 20037 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-13 |
| Decision Date | 2016-02-25 |
| Summary: | summary |