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FDA 510(k)

Dental Cone-beam Computed Tomography (FinScan F350)

K-Number: K242805 · 2025-01-09

ApplicantChangzhou Finno Medical Technology Co., Ltd.
Decision Date2025-01-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental Cone-beam Computed Tomography (FinScan F350) is a medical device manufactured by Changzhou Finno Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-09 under approval number K242805. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Cone-beam Computed Tomography (FinScan F350)?

Dental Cone-beam Computed Tomography (FinScan F350) is a medical device that received FDA 510(k) clearance on 2025-01-09. It is manufactured by Changzhou Finno Medical Technology Co., Ltd.. The 510(k) number is K242805.

When was Dental Cone-beam Computed Tomography (FinScan F350) approved by the FDA?

Dental Cone-beam Computed Tomography (FinScan F350) received FDA 510(k) clearance on 2025-01-09, under approval number K242805.

What company makes Dental Cone-beam Computed Tomography (FinScan F350)?

Dental Cone-beam Computed Tomography (FinScan F350) is manufactured by Changzhou Finno Medical Technology Co., Ltd..

What is the FDA product code for Dental Cone-beam Computed Tomography (FinScan F350)?

The FDA product code for Dental Cone-beam Computed Tomography (FinScan F350) is OAS.

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Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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