The following data is part of a premarket notification filed by Cablon Medical B.v. with the FDA for Theraview Tbi.
| Device ID | K170058 |
| 510k Number | K170058 |
| Device Name: | TheraView TBI |
| Classification | Accelerator, Linear, Medical |
| Applicant | Cablon Medical B.V. Klepelhoek 11 Leusden, NL 3833 Gz |
| Contact | Jurjen Weistra |
| Correspondent | Jurjen Weistra Cablon Medical B.V. Klepelhoek 11 Leusden, NL 3833 Gz |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-06 |
| Decision Date | 2017-03-03 |