FDA 510(k)

牙科圓锥束計算機斷層掃描系統

K 號：K260662 · 2026-06-04

決定日期2026-06-04

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

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 2026-06-04 under 510(k) number K260662. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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 2026-06-04. The listed applicant is Yofo Medical Technology Co., Ltd.. The 510(k) number is K260662.

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 2026-06-04, under 510(k) number K260662.

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.

其他以 Yofo Medical Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243337牙科圓锥束計算機斷層掃描系統

相關器械（代碼：OAS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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