The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Integrated Brachytherapy Unit - Digital.
| Device ID | K072445 |
| 510k Number | K072445 |
| Device Name: | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL |
| Classification | System, Simulation, Radiation Therapy |
| 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 | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-30 |
| Decision Date | 2007-09-14 |
| Summary: | summary |