Data / Medical devices / China / Keya Medical Technology Co.,ltd.
Keya Medical Technology Co.,ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Keya Medical Technology Co.,ltd. is registered with the FDA (registration 3025430791) in Beijing, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025430791
- Address
- No.1502-1, 1502-2, 1502-3, Floor 15, Building 1, Yard No.1, Ronghua South Road,Beijing Economic-Technological, Beijing, China, 100176
- Owner or operator
- Keya Medical Technology Co.,Ltd. (10086516)
- Roles
- Manufacturer
- First device listed
- November 15, 2022
- Registered through
- 2026
- Brand names listed
- DEEPVESSEL FFR, DEEPVESSEL Plaque
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Coronary Vascular Physiologic Simulation Software | PJA | 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 |
|---|---|---|---|---|---|---|
| June 4, 2026 | K260497 | DEEPVESSEL Plaque | QIH | Substantially Equivalent | Keya Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 1, 2022 | K213657 | DEEPVESSEL FFR | PJA | Substantially Equivalent | Keyamed Na, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Coronary Vascular Physiologic Simulation Software
Updated June 4, 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.