免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

檢視設備名稱醫療設備規範文本 檢視設備名稱醫療設備規範文本

K 號:K253639 · 2026-01-08

申請人GE Healthcare
決定日期2026-01-08
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

View is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K253639. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the View?

View is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is GE Healthcare. The 510(k) number is K253639.

When did View receive FDA 510(k) clearance?

View received FDA 510(k) clearance on 2026-01-08, under 510(k) number K253639.

Who is the listed applicant for View?

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

What is the FDA product code for View?

The FDA product code for View is LLZ.

相關 PubMed 文獻

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。

其他以 GE Healthcare 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。

查看所有 55 項裝置 →

相關器械(代碼:LLZ)

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑