Dental Cone-beam Computed Tomography (FinScan F350)— 510(k) K242805

Name: FDA 510(k) clearance K242805
Creator: U.S. Food and Drug Administration
Published: 2025-01-09

Substantially Equivalent

Changzhou Finno Medical Technology Co., Ltd.

FDA 510(k) clearance K242805 for Dental Cone-beam Computed Tomography (FinScan F350), Substantially Equivalent on 2025-01-09. Applicant: Changzhou Finno Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Finno Medical Technology Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2024-09-17
Decision date: 2025-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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