K250963 is an FDA 510(k) clearance for the PlanOne 1. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Cosylab Jsc, Control System Laboratory (Ljubljana, SI). The FDA issued a Cleared decision on November 20, 2025, 234 days after receiving the submission on March 31, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K250963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | November 20, 2025 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ - System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |