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FDA 510(k)

一標

K 號：K241762 · 2024-09-16

申請人View Point Medical
決定日期2024-09-16
產品代碼NEU
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

OneMark is the device name listed in this FDA 510(k) record. The listed applicant is View Point Medical. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241762. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OneMark?

OneMark is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is View Point Medical. The 510(k) number is K241762.

When did OneMark receive FDA 510(k) clearance?

OneMark received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241762.

Who is the listed applicant for OneMark?

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

What is the FDA product code for OneMark?

The FDA product code for OneMark is NEU.

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：NEU）

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。

K253761HydroMARK™ Plus 乳癌切片位置標記器（龍飛形狀）；HydroMARK™ Plus 乳癌切片位置標記器（蜂鳥形狀）Devicor Medical Products, Inc.K253888MOLLI 2 系統Stryker EndoscopyK252892SCOUT MD 外科導航系統Merit Medical Systems, Inc.K251989VizMark 預載組織標記設備（VM-0001）Breast-Med, Inc.K251748MammoSTAR 繭組切片位置識別器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳組織標記器Bard Peripheral Vascular, Inc.

官方來源

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