The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Raycast Mammorx Carbon Fibre Breast Board.
| Device ID | K162355 |
| 510k Number | K162355 |
| Device Name: | Raycast MammoRx Carbon Fibre Breast Board |
| Classification | Accelerator, Linear, Medical |
| Applicant | Orfit Industries NV 9A, VOSVELD Wijnegem, BE 2110 |
| Contact | Eddy Marivoet |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Ter Southbury, CT 06488 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2016-11-22 |