MRIA Radiation Therapy Information System (MRIA)— 510(k) K260733
Substantially EquivalentManteia Technologies Co., Ltd.
FDA 510(k) clearance K260733 for MRIA Radiation Therapy Information System (MRIA), Substantially Equivalent on 2026-08-26. Applicant: Manteia Technologies Co., Ltd.. Device class: 2.
Summary
Manteia Technologies filed the MRIA Radiation Therapy Information System under product code IYE, medical linear accelerators. The record doesn't expand MRIA.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Manteia filed from Xiamen, China. FDA found it substantially equivalent 173 calendar days after receipt (March 6 to August 26, 2026).
Clearance details
- Applicant
- Manteia Technologies Co., Ltd.
- Product code
- Product code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
Recent devices under product code IYE
view allMore clearances from Manteia Technologies Co., Ltd.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.