免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

自動解剖識別(AAR)

K 號:K203610 · 2021-04-20

決定日期2021-04-20
產品代碼QKB
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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。

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑