FDA AI Clearance Tracker/K260497
Radiology · 510(k)
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
- Device
- DEEPVESSEL Plaque
- Company
- Keya Medical Technology Co., Ltd.
- Submission number
- K260497
- Pathway
- 510(k)
- Decision date
- Jun 4, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- QIH
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.