Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )— 510(k) K251438

Name: FDA 510(k) clearance K251438
Creator: U.S. Food and Drug Administration
Published: 2025-09-04

Substantially Equivalent

Guilin Woodpecker Medical Instrument Co., Ltd.

FDA 510(k) clearance K251438 for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ), Substantially Equivalent on 2025-09-04. Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2025-05-09
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Guilin Woodpecker Medical Instrument Co., Ltd.

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