FDA 510(k)

數據分析輔助套件（DAFS）

K 號：K253944 · 2026-03-16

申請人Voronoi Health Analytics Incorporated

決定日期2026-03-16

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Data Analysis Facilitation Suite (DAFS) is the device name listed in this FDA 510(k) record. The listed applicant is Voronoi Health Analytics Incorporated. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253944. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Data Analysis Facilitation Suite (DAFS)?

Data Analysis Facilitation Suite (DAFS) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Voronoi Health Analytics Incorporated. The 510(k) number is K253944.

When did Data Analysis Facilitation Suite (DAFS) receive FDA 510(k) clearance?

Data Analysis Facilitation Suite (DAFS) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253944.

Who is the listed applicant for Data Analysis Facilitation Suite (DAFS)?

The FDA 510(k) record lists Voronoi Health Analytics Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Data Analysis Facilitation Suite (DAFS)?

The FDA product code for Data Analysis Facilitation Suite (DAFS) is QIH.

相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QIH）

官方來源