Dental Cone-beam Computed Tomography— 510(k) K240855

Name: FDA 510(k) clearance K240855
Creator: U.S. Food and Drug Administration
Published: 2024-04-25

Substantially Equivalent

Yian Medical Technology (Haining) Co., Ltd.

FDA 510(k) clearance K240855 for Dental Cone-beam Computed Tomography, Substantially Equivalent on 2024-04-25. 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: 2024-03-28
Decision date: 2024-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Haining, Jiaxing, 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.