E1000 Dx 電子病理學解決方案
K 號：K241717 · 2025-02-28
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器材摘要
E1000 Dx Digital Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Shandon Diagnostics Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241717. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the E1000 Dx Digital Pathology Solution?
E1000 Dx Digital Pathology Solution is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Shandon Diagnostics Limited. The 510(k) number is K241717.
When did E1000 Dx Digital Pathology Solution receive FDA 510(k) clearance?
E1000 Dx Digital Pathology Solution received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241717.
Who is the listed applicant for E1000 Dx Digital Pathology Solution?
The FDA 510(k) record lists Shandon Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E1000 Dx Digital Pathology Solution?
The FDA product code for E1000 Dx Digital Pathology Solution is PSY.
相關臨床試驗
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相關器械（代碼：PSY）
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
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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