FDA 510(k)

牙科計算機斷層掃描X光系統，綠X

K 號：K201627 · 2020-10-27

決定日期2020-10-27

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Dental Computed Tomography X-Ray System, Green X is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2020-10-27 under 510(k) number K201627. 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 Computed Tomography X-Ray System, Green X?

Dental Computed Tomography X-Ray System, Green X is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K201627.

When did Dental Computed Tomography X-Ray System, Green X receive FDA 510(k) clearance?

Dental Computed Tomography X-Ray System, Green X received FDA 510(k) clearance on 2020-10-27, under 510(k) number K201627.

Who is the listed applicant for Dental Computed Tomography X-Ray System, Green X?

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

What is the FDA product code for Dental Computed Tomography X-Ray System, Green X?

The FDA product code for Dental Computed Tomography X-Ray System, Green X is OAS.

其他以 VATECH 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。

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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。

K261748牙科圓錐束計算機斷層掃描儀（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科X光系統Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科圓锥束計算機斷層掃描系統Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093綠色X 12 VE (PHT-70CHS)；綠色X VE (PHT-70CHS)VATECH Co., Ltd.

官方來源

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