FDA 510(k)

Synapse 肺結節 AI

K 號：K254075 · 2026-05-27

決定日期2026-05-27

產品代碼OEB

諮詢委員會RA

決定相當於

器材摘要

Synapse Lung Nodule AI is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254075. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Synapse Lung Nodule AI?

Synapse Lung Nodule AI is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Fujifilm Corporation. The 510(k) number is K254075.

When did Synapse Lung Nodule AI receive FDA 510(k) clearance?

Synapse Lung Nodule AI received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254075.

Who is the listed applicant for Synapse Lung Nodule AI?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Synapse Lung Nodule AI?

The FDA product code for Synapse Lung Nodule AI is OEB.

其他以 Fujifilm Corporation 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。

K261229SCENARIA 觀察階段 6.0 K261283APERTO Lucent MRI 系統 K253836FCT iStream 階段 2 K261170BA-004CC K260567EW10-EC02內視鏡輔助程序 K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01

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相關器械（代碼：OEB）

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。

K251203AVIEW肺結節計算機輔助診斷Coreline Soft Co., Ltd.K240554InferRead 肺部 CT.AIInfervision Medical Technology Co., Ltd.K242919V5med 肺部AIV5med, Inc.K231157syngo.CT 肺部 CAD（版本 VD30）Siemens Healthcare GmbH K221592AVIEW肺結節計算機輔助診斷Coreline Soft Co., Ltd.K221612ClearRead CTRiverain Technologies, Inc.

官方來源

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