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FDA 510(k)

安全CT-29

K 號:K153331 · 2016-05-17

決定日期2016-05-17
產品代碼JAK
諮詢委員會RA
決定相當於

器材摘要

SafeCT-29 is the device name listed in this FDA 510(k) record. The listed applicant is Medic Vision Imaging Solutions. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153331. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SafeCT-29?

SafeCT-29 is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Medic Vision Imaging Solutions. The 510(k) number is K153331.

When did SafeCT-29 receive FDA 510(k) clearance?

SafeCT-29 received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153331.

Who is the listed applicant for SafeCT-29?

The FDA 510(k) record lists Medic Vision Imaging Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeCT-29?

The FDA product code for SafeCT-29 is JAK.

相關臨床試驗

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相關器械(代碼:JAK)

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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