QuantX 乳癌 MRI 結合針吸切片引導外掛式軟體
K 號：K191959 · 2019-11-08
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器材摘要
QuantX Breast MRI Biopsy Guidance Plugin is the device name listed in this FDA 510(k) record. The listed applicant is Qlarity Imaging. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191959. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the QuantX Breast MRI Biopsy Guidance Plugin?
QuantX Breast MRI Biopsy Guidance Plugin is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Qlarity Imaging. The 510(k) number is K191959.
When did QuantX Breast MRI Biopsy Guidance Plugin receive FDA 510(k) clearance?
QuantX Breast MRI Biopsy Guidance Plugin received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191959.
Who is the listed applicant for QuantX Breast MRI Biopsy Guidance Plugin?
The FDA 510(k) record lists Qlarity Imaging as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QuantX Breast MRI Biopsy Guidance Plugin?
The FDA product code for QuantX Breast MRI Biopsy Guidance Plugin is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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。
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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