正骨科AI
K 號：K241696 · 2025-01-02
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器材摘要
Ortho AI is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Ai, LLC. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K241696. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ortho AI?
Ortho AI is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Ortho Ai, LLC. The 510(k) number is K241696.
When did Ortho AI receive FDA 510(k) clearance?
Ortho AI received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241696.
Who is the listed applicant for Ortho AI?
The FDA 510(k) record lists Ortho Ai, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ortho AI?
The FDA product code for Ortho AI is QIH.
相關臨床試驗
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相關器械（代碼：QIH）
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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