The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Plato-srs(stereo Radiosurgery Treatment Planning Sys).
| Device ID | K940001 |
| 510k Number | K940001 |
| Device Name: | PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) |
| Classification | Accelerator, Linear, Medical |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | S.p. Teague |
| Correspondent | S.p. Teague 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 | 1994-01-03 |
| Decision Date | 1995-11-14 |