The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Spot Pro (220v), Model 131.099.
| Device ID | K022741 |
| 510k Number | K022741 |
| Device Name: | SPOT PRO (220V), MODEL 131.099 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON CORPORATION 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick NUCLETRON CORPORATION 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2133 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-19 |
| Decision Date | 2002-10-24 |
| Summary: | summary |