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)

影像品質分析器 (IQA)

K 號:K200422 · 2020-12-24

決定日期2020-12-24
產品代碼NFJ
諮詢委員會RA
決定相當於

器材摘要

Image Quality Analyzer (IQA) is the device name listed in this FDA 510(k) record. The listed applicant is Visionquest Biomedical, Inc.. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K200422. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Image Quality Analyzer (IQA)?

Image Quality Analyzer (IQA) is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Visionquest Biomedical, Inc.. The 510(k) number is K200422.

When did Image Quality Analyzer (IQA) receive FDA 510(k) clearance?

Image Quality Analyzer (IQA) received FDA 510(k) clearance on 2020-12-24, under 510(k) number K200422.

Who is the listed applicant for Image Quality Analyzer (IQA)?

The FDA 510(k) record lists Visionquest Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Quality Analyzer (IQA)?

The FDA product code for Image Quality Analyzer (IQA) is NFJ.

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:NFJ)

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。

↑