Dental Computed Tomography X-ray System— 510(k) K251842

Name: FDA 510(k) clearance K251842
Creator: U.S. Food and Drug Administration
Published: 2025-11-13

Substantially Equivalent

Fussen Technology Co., Ltd.

FDA 510(k) clearance K251842 for Dental Computed Tomography X-ray System, Substantially Equivalent on 2025-11-13. Applicant: Fussen Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fussen Technology Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2025-06-16
Decision date: 2025-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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