The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Nucletron Planning System.
| Device ID | K911612 |
| 510k Number | K911612 |
| Device Name: | NUCLETRON PLANNING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
| Contact | A. M Mount |
| Correspondent | A. M 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 | 1991-04-11 |
| Decision Date | 1991-06-13 |