Dental CBCT X-ray System— 510(k) K251642

Name: FDA 510(k) clearance K251642
Creator: U.S. Food and Drug Administration
Published: 2025-06-27

Substantially Equivalent

Yian Medical Technology (Haining) Co., Ltd.

FDA 510(k) clearance K251642 for Dental CBCT X-ray System, Substantially Equivalent on 2025-06-27. Applicant: Yian Medical Technology (Haining) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yian Medical Technology (Haining) Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2025-05-29
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Haining, Jiaxing, CN

Download summary PDF View on FDA.gov ↗

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