The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Plato Radiation Therapy Planning System.
| Device ID | K921991 |
| 510k Number | K921991 |
| Device Name: | PLATO RADIATION THERAPY PLANNING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
| Contact | Mount |
| Correspondent | Mount NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1992-11-27 |