可攜式牙科X光系統型號 PDX nova
K 號：K260367 · 2026-05-27
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器材摘要
Portable Dental X-ray System Model PDX nova is the device name listed in this FDA 510(k) record. The listed applicant is PDX Co., Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260367. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Portable Dental X-ray System Model PDX nova?
Portable Dental X-ray System Model PDX nova is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is PDX Co., Ltd.. The 510(k) number is K260367.
When did Portable Dental X-ray System Model PDX nova receive FDA 510(k) clearance?
Portable Dental X-ray System Model PDX nova received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260367.
Who is the listed applicant for Portable Dental X-ray System Model PDX nova?
The FDA 510(k) record lists PDX Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable Dental X-ray System Model PDX nova?
The FDA product code for Portable Dental X-ray System Model PDX nova is EHD.
相關臨床試驗
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相關器械（代碼：EHD）
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
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