The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Nucletron Plato External Beam Planning Rts V2 And Rts 3d V2.
| Device ID | K964206 |
| 510k Number | K964206 |
| Device Name: | NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Randolph Hemingway |
| Correspondent | Randolph Hemingway 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 | 1996-10-21 |
| Decision Date | 1997-06-20 |
| Summary: | summary |