乳房BI 7 MR 線圈 Mammavention 3T
K 號：K162651 · 2017-01-18
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器材摘要
Breast BI 7 MR Coil Mammavention 3T is the device name listed in this FDA 510(k) record. The listed applicant is Moras Mri Products GmbH. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K162651. 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 Breast BI 7 MR Coil Mammavention 3T?
Breast BI 7 MR Coil Mammavention 3T is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Moras Mri Products GmbH. The 510(k) number is K162651.
When did Breast BI 7 MR Coil Mammavention 3T receive FDA 510(k) clearance?
Breast BI 7 MR Coil Mammavention 3T received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162651.
Who is the listed applicant for Breast BI 7 MR Coil Mammavention 3T?
The FDA 510(k) record lists Moras Mri Products GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breast BI 7 MR Coil Mammavention 3T?
The FDA product code for Breast BI 7 MR Coil Mammavention 3T is MOS.
相關臨床試驗
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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
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