K234068 is an FDA 510(k) clearance for the ART-Plan (v.2.2.0). This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Therapanacea Sas (Paris, FR). The FDA issued a Cleared decision on April 22, 2024, 122 days after receiving the submission on December 22, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K234068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | April 22, 2024 |
| Days to Decision | 122 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 |