FDA 510(k)

uAI EasyTriage-Rib FDA（米国食品医薬品局）、510(k)、PMA（プレマーケティング評価）、NCT（治験登録番号）、PMID（PubMed ID）および識別子、URLはそのままに保持してください。

K番号: K193271 · 2021-01-15

申請者Shanghai United Imaging Intelligence Co., Ltd.

決定日2021-01-15

製品コードQFM

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

uAI EasyTriage-Rib is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K193271. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the uAI EasyTriage-Rib?

uAI EasyTriage-Rib is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K193271.

When did uAI EasyTriage-Rib receive FDA 510(k) clearance?

uAI EasyTriage-Rib received FDA 510(k) clearance on 2021-01-15, under 510(k) number K193271.

Who is the listed applicant for uAI EasyTriage-Rib?

The FDA 510(k) record lists Shanghai United Imaging Intelligence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uAI EasyTriage-Rib?

The FDA product code for uAI EasyTriage-Rib is QFM.

申請者としてShanghai United Imaging Intelligence Co., Ltd.を記載するその他の記録

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