FDA 510(k)

RCT600

K 號：K243903 · 2025-03-12

決定日期2025-03-12

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

RCT600 is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K243903. 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 RCT600?

RCT600 is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Ray Co., Ltd.. The 510(k) number is K243903.

When did RCT600 receive FDA 510(k) clearance?

RCT600 received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243903.

Who is the listed applicant for RCT600?

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

What is the FDA product code for RCT600?

The FDA product code for RCT600 is OAS.

其他以 Ray 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。

K260462RCT800 K251798RCT700 K251109SMARTDent K233625瑞德恩 SW K232325RAYSkan a-Expert K232287RAYSCAN a-Expert3D

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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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