The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Oncentra-visir.
| Device ID | K041719 |
| 510k Number | K041719 |
| Device Name: | ONCENTRA-VISIR |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON CORP. 8671 ROBERT FULTON DRIVE Columbia, MD 21046 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick NUCLETRON CORP. 8671 ROBERT FULTON DRIVE Columbia, MD 21046 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-24 |
| Decision Date | 2004-07-22 |
| Summary: | summary |