FDA 510(k)

牙科锥形束CT系统

K号: K243337 · 2025-04-17

决定日期2025-04-17

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Dental Cone Beam Computed Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Yofo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K243337. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Yofo Medical Technology Co., Ltd.. The 510(k) number is K243337.

When did Dental Cone Beam Computed Tomography System receive FDA 510(k) clearance?

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

Who is the listed applicant for Dental Cone Beam Computed Tomography System?

The FDA 510(k) record lists Yofo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Yofo Medical Technology Co., Ltd.为申报人的其他记录

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K260662牙科锥形束CT系统

官方来源

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