The following data is part of a premarket notification filed by Indiana University Cyclotron Facility with the FDA for Proton Therapy System.
| Device ID | K062891 |
| 510k Number | K062891 |
| Device Name: | PROTON THERAPY SYSTEM |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | INDIANA UNIVERSITY CYCLOTRON FACILITY 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INDIANA UNIVERSITY CYCLOTRON FACILITY 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2006-12-14 |
| Summary: | summary |