The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Raycast High Precision Lung Board Solution.
| Device ID | K162862 |
| 510k Number | K162862 |
| Device Name: | Raycast High Precision Lung Board Solution |
| Classification | Accelerator, Linear, Medical |
| Applicant | Orfit Industries NV 9A VOSVELD Wijnegem, BE 2110 |
| Contact | Raymond Kelly |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-10-12 |
| Decision Date | 2016-11-09 |
| Summary: | summary |