三麗珠橢圓頭線圈 32
K 號：K162079 · 2016-09-16
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器材摘要
TRILLIUM Oval Head Coil 32 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K162079. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TRILLIUM Oval Head Coil 32?
TRILLIUM Oval Head Coil 32 is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K162079.
When did TRILLIUM Oval Head Coil 32 receive FDA 510(k) clearance?
TRILLIUM Oval Head Coil 32 received FDA 510(k) clearance on 2016-09-16, under 510(k) number K162079.
Who is the listed applicant for TRILLIUM Oval Head Coil 32?
The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRILLIUM Oval Head Coil 32?
The FDA product code for TRILLIUM Oval Head Coil 32 is MOS.
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。
其他以 Hitachi Medical Systems America, Inc. 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：MOS）
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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