The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Vss, Virtual Simulation System.
| Device ID | K980629 |
| 510k Number | K980629 |
| Device Name: | VSS, VIRTUAL SIMULATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-05-06 |
| Summary: | summary |