The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Ibu, Integrated Brachy Therapy Unit.
| Device ID | K973848 |
| 510k Number | K973848 |
| Device Name: | IBU, INTEGRATED BRACHY THERAPY UNIT |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Ralph E Shuping |
| Correspondent | Ralph E Shuping NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1998-01-22 |
| Summary: | summary |