ENCOMPASS 鷹3D CBCT/全景/頭影學牙齒X光機
K 號：K152489 · 2016-02-04
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器材摘要
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is Panoramic Corp.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152489. 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 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Panoramic Corp.. The 510(k) number is K152489.
When did ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray receive FDA 510(k) clearance?
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152489.
Who is the listed applicant for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?
The FDA 510(k) record lists Panoramic Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?
The FDA product code for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is OAS.
相關臨床試驗
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
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