K260497
- 510(k) number
- K260497
- Device name
- DEEPVESSEL Plaque
- Applicant
- Keya Medical Technology Co., Ltd. CN
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-04
- Date received
- 2026-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260497.pdf
Official FDA record: K260497
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.