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FDA 510(k)

SpineUs™ 系統

K 號：K241029 · 2024-10-07

申請人Verdure Imaging
決定日期2024-10-07
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

SpineUs™ System is the device name listed in this FDA 510(k) record. The listed applicant is Verdure Imaging. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K241029. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpineUs™ System?

SpineUs™ System is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Verdure Imaging. The 510(k) number is K241029.

When did SpineUs™ System receive FDA 510(k) clearance?

SpineUs™ System received FDA 510(k) clearance on 2024-10-07, under 510(k) number K241029.

Who is the listed applicant for SpineUs™ System?

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

What is the FDA product code for SpineUs™ System?

The FDA product code for SpineUs™ System is IYO.

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：IYO）

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。

K260313MD-6000S 膀胱掃描儀MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT 扫描儀 2000 型號 AQT Imaging Holdings, Inc.

官方來源

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