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FDA 510(k)

牙科圓锥束計算機斷層掃描儀（FinScan F350）

K 號：K242805 · 2025-01-09

申請人Changzhou Finno Medical Technology Co., Ltd.
決定日期2025-01-09
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 (FinScan F350) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-09 under 510(k) number K242805. 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 (FinScan F350)?

Dental Cone-beam Computed Tomography (FinScan F350) is a medical device that received FDA 510(k) clearance on 2025-01-09. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. The 510(k) number is K242805.

When did Dental Cone-beam Computed Tomography (FinScan F350) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (FinScan F350) received FDA 510(k) clearance on 2025-01-09, under 510(k) number K242805.

Who is the listed applicant for Dental Cone-beam Computed Tomography (FinScan F350)?

The FDA 510(k) record lists Changzhou Finno 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 (FinScan F350)?

The FDA product code for Dental Cone-beam Computed Tomography (FinScan F350) is OAS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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