The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Ocentra Masterplan 3.1 (ocentra Brachy).
| Device ID | K081281 |
| 510k Number | K081281 |
| Device Name: | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-06 |
| Decision Date | 2008-05-20 |
| Summary: | summary |