The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Itp, Model 1.0.
| Device ID | K992434 |
| 510k Number | K992434 |
| Device Name: | ITP, MODEL 1.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| 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 | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-21 |
| Decision Date | 2000-01-13 |
| Summary: | summary |