正位顎骨攝影機 OP 3D
K 號：K170813 · 2017-04-07
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器材摘要
ORTHOPANTOMOGRAPH OP 3D 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 2017-04-07 under 510(k) number K170813. 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?
ORTHOPANTOMOGRAPH OP 3D is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Palodex Group OY. The 510(k) number is K170813.
When did ORTHOPANTOMOGRAPH OP 3D receive FDA 510(k) clearance?
ORTHOPANTOMOGRAPH OP 3D received FDA 510(k) clearance on 2017-04-07, under 510(k) number K170813.
Who is the listed applicant for ORTHOPANTOMOGRAPH OP 3D?
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?
The FDA product code for ORTHOPANTOMOGRAPH OP 3D 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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