UniSyn 分子影像設備（6-3-1）
K 號：K231047 · 2023-09-01
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器材摘要
UniSyn Molecular Imaging (6-3-1) is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Imaging Solutions. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231047. 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 UniSyn Molecular Imaging (6-3-1)?
UniSyn Molecular Imaging (6-3-1) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Convergent Imaging Solutions. The 510(k) number is K231047.
When did UniSyn Molecular Imaging (6-3-1) receive FDA 510(k) clearance?
UniSyn Molecular Imaging (6-3-1) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231047.
Who is the listed applicant for UniSyn Molecular Imaging (6-3-1)?
The FDA 510(k) record lists Convergent Imaging Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UniSyn Molecular Imaging (6-3-1)?
The FDA product code for UniSyn Molecular Imaging (6-3-1) 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
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