SuniIQ數位X光攝影系統
K 號：K162585 · 2016-11-04
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器材摘要
SuniIQ Digital Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162585. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SuniIQ Digital Radiography System?
SuniIQ Digital Radiography System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Suni Medical Imaging, Inc.. The 510(k) number is K162585.
When did SuniIQ Digital Radiography System receive FDA 510(k) clearance?
SuniIQ Digital Radiography System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162585.
Who is the listed applicant for SuniIQ Digital Radiography System?
The FDA 510(k) record lists Suni Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SuniIQ Digital Radiography System?
The FDA product code for SuniIQ Digital Radiography System is MUH.
相關臨床試驗
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相關器械（代碼：MUH）
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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