The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Oncentra Brachy.
| Device ID | K132816 |
| 510k Number | K132816 |
| Device Name: | ONCENTRA BRACHY |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON B.V. 1917 29 3/4 AVE. Rice Lake, WI 54868 |
| Contact | Lu Anne Johnson |
| Correspondent | Lu Anne Johnson NUCLETRON B.V. 1917 29 3/4 AVE. Rice Lake, WI 54868 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-06-13 |
| Summary: | summary |