Radlink GPS Pro 医療設備規範文本
K 號：K242161 · 2025-03-18
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器材摘要
Radlink GPS Pro Imaging is the device name listed in this FDA 510(k) record. The listed applicant is Radlink, Inc.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K242161. 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 Radlink GPS Pro Imaging?
Radlink GPS Pro Imaging is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Radlink, Inc.. The 510(k) number is K242161.
When did Radlink GPS Pro Imaging receive FDA 510(k) clearance?
Radlink GPS Pro Imaging received FDA 510(k) clearance on 2025-03-18, under 510(k) number K242161.
Who is the listed applicant for Radlink GPS Pro Imaging?
The FDA 510(k) record lists Radlink, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Radlink GPS Pro Imaging?
The FDA product code for Radlink GPS Pro Imaging is LLZ.
相關臨床試驗
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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。
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