RADspeed Pro
K 號：K152244 · 2016-06-20
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器材摘要
RADspeed Pro is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K152244. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RADspeed Pro?
RADspeed Pro is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Shimadzu Corporation. The 510(k) number is K152244.
When did RADspeed Pro receive FDA 510(k) clearance?
RADspeed Pro received FDA 510(k) clearance on 2016-06-20, under 510(k) number K152244.
Who is the listed applicant for RADspeed Pro?
The FDA 510(k) record lists Shimadzu Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RADspeed Pro?
The FDA product code for RADspeed Pro is KPR.
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其他以 Shimadzu Corporation 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：KPR）
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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