FDA 510(k)

自動解剖認識（AAR）

K番号: K203610 · 2021-04-20

申請者Quantitative Radiology Solutions, LLC

決定日2021-04-20

製品コードQKB

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

Automatic Anatomy Recognition (AAR) is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative Radiology Solutions, LLC. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203610. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Automatic Anatomy Recognition (AAR)?

Automatic Anatomy Recognition (AAR) is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Quantitative Radiology Solutions, LLC. The 510(k) number is K203610.

When did Automatic Anatomy Recognition (AAR) receive FDA 510(k) clearance?

Automatic Anatomy Recognition (AAR) received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203610.

Who is the listed applicant for Automatic Anatomy Recognition (AAR)?

The FDA 510(k) record lists Quantitative Radiology Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Anatomy Recognition (AAR)?

The FDA product code for Automatic Anatomy Recognition (AAR) is QKB.

公式ソース

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自動解剖認識（AAR）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：QKB）

公式ソース