DEEPVESSEL Plaque— 510(k) K260497

Name: FDA 510(k) clearance K260497
Creator: U.S. Food and Drug Administration
Published: 2026-06-04

Substantially Equivalent

Keya Medical Technology Co., Ltd.

FDA 510(k) clearance K260497 for DEEPVESSEL Plaque, Substantially Equivalent on 2026-06-04. Applicant: Keya Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Keya Medical Technology Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-13
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.