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FDA 510(k)

Dental Cone Beam Computed Tomography System

K-Number: K243337 · 2025-04-17

ApplicantYofo Medical Technology Co., Ltd.
Decision Date2025-04-17
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental Cone Beam Computed Tomography System is a medical device manufactured by Yofo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-17 under approval number K243337. 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 System?

Dental Cone Beam Computed Tomography System is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Yofo Medical Technology Co., Ltd.. The 510(k) number is K243337.

When was Dental Cone Beam Computed Tomography System approved by the FDA?

Dental Cone Beam Computed Tomography System received FDA 510(k) clearance on 2025-04-17, under approval number K243337.

What company makes Dental Cone Beam Computed Tomography System?

Dental Cone Beam Computed Tomography System is manufactured by Yofo Medical Technology Co., Ltd..

What is the FDA product code for Dental Cone Beam Computed Tomography System?

The FDA product code for Dental Cone Beam Computed Tomography System 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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