The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Proton Immobilization Solution.
| Device ID | K151207 |
| 510k Number | K151207 |
| Device Name: | Proton Immobilization Solution |
| Classification | Accelerator, Linear, Medical |
| Applicant | ORFIT INDUSTRIES NV VOSVELD 9A Wijnegem, BE B-2110 |
| Contact | Eddy Marivoet |
| Correspondent | Lee Leichter P/L BIOMEDICAL 10882 STONINGTON AVE. Fort Myers, FL 33913 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-07-28 |