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FDA 510(k)

SpotLight / SpotLight Duo 內建低劑量肺臟癌檢查選項

K 號：K250650 · 2025-04-15

申請人Arineta , Ltd.
決定日期2025-04-15
產品代碼JAK
諮詢委員會RA
決定相當於

器材摘要

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250650. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Arineta , Ltd.. The 510(k) number is K250650.

When did SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option receive FDA 510(k) clearance?

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250650.

Who is the listed applicant for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

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

What is the FDA product code for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

The FDA product code for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is JAK.

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

其他以 Arineta , 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：JAK）

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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官方來源

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