FDA 510(k)

綠色X 12 VE (PHT-70CHS)；綠色X VE (PHT-70CHS)

K 號：K260093 · 2026-03-31

決定日期2026-03-31

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) 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 2026-03-31 under 510(k) number K260093. 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 Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) is a medical device that received FDA 510(k) clearance on 2026-03-31. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K260093.

When did Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) receive FDA 510(k) clearance?

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) received FDA 510(k) clearance on 2026-03-31, under 510(k) number K260093.

Who is the listed applicant for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?

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 Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?

The FDA product code for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) 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。

K243088綠色X 12 SE (PHT-40CHS)K243081綠色X 21 (PHT-90CHO)K240040VistaPano S Ceph 2.0 (VistaPano S Ceph)；VistaPano S 2.0 (VistaPano S)；ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph)；ProVecta S-Pan 2.0 (ProVecta S-Pan)K231796Grreen X 12（型號：PHT-75CHS）K223058EzRay Air 2 Wall（型號：VEX-S350W）K213462EzRay M18（型號：VMX-P400）

查看所有 18 項裝置 →

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.K252353myray ProXIma X6Cefla S.C.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。