正側位全景攝影儀™ OP 3D LX
K 號：K230505 · 2023-06-09
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器材摘要
Orthopantomograph™ OP 3D LX is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230505. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Orthopantomograph™ OP 3D LX?
Orthopantomograph™ OP 3D LX is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Palodex Group OY. The 510(k) number is K230505.
When did Orthopantomograph™ OP 3D LX receive FDA 510(k) clearance?
Orthopantomograph™ OP 3D LX received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230505.
Who is the listed applicant for Orthopantomograph™ OP 3D LX?
The FDA 510(k) record lists Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthopantomograph™ OP 3D LX?
The FDA product code for Orthopantomograph™ OP 3D LX is OAS.
相關臨床試驗
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其他以 Palodex Group OY 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。
相關器械（代碼：OAS）
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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