FDA 510(k)

RT-Mind-AI 医療設備規範文本 RT-Mind-AI 医療設備，已通過FDA認證，符合510(k)規定，並獲得PMA許可。該設備參與的臨床試驗代號為NCT，並在PubMed上登錄，編號為PMID。相關識別碼及URL如下：[識別碼/URL]。注意：本翻譯遵循「medical-regulatory-v1」政策，公司名稱及產品名稱未進行翻譯。

K 號：K213155 · 2021-12-15

決定日期2021-12-15

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

RT-Mind-AI is the device name listed in this FDA 510(k) record. The listed applicant is Medmind Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K213155. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RT-Mind-AI?

RT-Mind-AI is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Medmind Technology Co., Ltd.. The 510(k) number is K213155.

When did RT-Mind-AI receive FDA 510(k) clearance?

RT-Mind-AI received FDA 510(k) clearance on 2021-12-15, under 510(k) number K213155.

Who is the listed applicant for RT-Mind-AI?

The FDA 510(k) record lists Medmind Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT-Mind-AI?

The FDA product code for RT-Mind-AI is QKB.

相關器械（代碼：QKB）

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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