The following data is part of a premarket notification filed by Nucletron with the FDA for Oncentra Prostate 4.0.
| Device ID | K112420 |
| 510k Number | K112420 |
| Device Name: | ONCENTRA PROSTATE 4.0 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON 7021 COLUMBIA GATEWAY DRIVE SUITE 200 Columbia, MD 21046 |
| Contact | Michael Paul |
| Correspondent | Michael Paul NUCLETRON 7021 COLUMBIA GATEWAY DRIVE SUITE 200 Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2011-11-18 |
| Summary: | summary |