The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Treatment Control Station - Microselectron-hdr Classic Upgrade, Version 1.20.
| Device ID | K983115 |
| 510k Number | K983115 |
| Device Name: | TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Ralph Shuping |
| Correspondent | Ralph Shuping NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. 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 | 1998-09-04 |
| Decision Date | 1999-04-02 |
| Summary: | summary |