Sentinella 102, Sentinella 102 賀拉斯
K 號：K162052 · 2016-08-18
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器材摘要
Sentinella 102, Sentinella 102 Horus is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sentinella 102, Sentinella 102 Horus?
Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.
When did Sentinella 102, Sentinella 102 Horus receive FDA 510(k) clearance?
Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under 510(k) number K162052.
Who is the listed applicant for Sentinella 102, Sentinella 102 Horus?
The FDA 510(k) record lists General Equipment For Medical Imaging (Oncovision- as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentinella 102, Sentinella 102 Horus?
The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.
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：IYX）
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。
K230221QDOSE® 多功能體素劑量學（分子放射治療個體化劑量學）Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXM 医療設備規範文本
注意：以下翻譯僅針對規範文本部分，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL等未進行翻譯。
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本設備名稱為OLINDA EXM，該設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請編號為[識別符]。該設備的臨床試驗編號為NCT[識別符]，並已在PubMed上發表，PMID編號為[識別符]。相關資訊請參考以下網址：[URL]。
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請注意，上述翻譯僅針對規範文本部分，並未翻譯公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL等。Hermes Medical Solutions ABK160933Discovery NM 750b 頸部切除術GE Healthcare
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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