K223724 is an FDA 510(k) clearance for the MOZI TPS. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Manteia Technologies Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on July 10, 2023, 209 days after receiving the submission on December 13, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K223724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2022 |
| Decision Date | July 10, 2023 |
| Days to Decision | 209 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 |