Data / Medical devices / China / Manteia Technologies Co.,ltd.
Manteia Technologies Co.,ltd.: FDA-registered device maker in Xiamen Fujian, China, 7 510(k) clearances
Manteia Technologies Co.,ltd. is registered with the FDA (registration 3016686005) in Xiamen Fujian, China. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016686005
- Address
- Unit 3001-3005, No.5 Huizhan North Road, Xiamen Fujian, China, 361000
- Owner or operator
- Manteia Technologies Co.,Ltd. (10062831)
- Roles
- Manufacturer
- First device listed
- March 11, 2020
- Registered through
- 2026
- Brand names listed
- ARTAssistant, AccuCheck, AccuCheck Radiotherapy Plan Quality Assurance System, AccuContour, AccuContour 4, MOZI TPS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2026 | K251351 | AccuContour 4.0 | QKB | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| December 5, 2025 | K250780 | ARTAssistant | QKB | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| October 24, 2025 | K250696 | AccuCheck | IYE | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| July 20, 2023 | K223834 | AccuCheck | IYE | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| July 10, 2023 | K223724 | MOZI TPS | MUJ | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| March 9, 2023 | K221706 | AccuContour | QKB | Substantially Equivalent | Manteia Technologies Co., Ltd. | accessdata.fda.gov |
| February 28, 2020 | K191928 | AccuContour | QKB | Substantially Equivalent | Xiamen Manteia Technology , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated January 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.