Diagnostic X-Ray Equipment Model POCT22— 510(k) K252909

Name: FDA 510(k) clearance K252909
Creator: U.S. Food and Drug Administration
Published: 2026-02-03

Substantially Equivalent

Ningbo Runyes Medical Instrument Co., Ltd.

FDA 510(k) clearance K252909 for Diagnostic X-Ray Equipment Model POCT22, Substantially Equivalent on 2026-02-03. Applicant: Ningbo Runyes Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Runyes Medical Instrument Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2025-09-12
Decision date: 2026-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo Zhejiang, CN

Download summary PDF View on FDA.gov ↗

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