FDA 510(k)

重症照護套件，配備腸管定位人工智慧演算法

K 號：K253502 · 2026-04-14

決定日期2026-04-14

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Critical Care Suite with Enteric Tube Positioning AI Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K253502. 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 Critical Care Suite with Enteric Tube Positioning AI Algorithm?

Critical Care Suite with Enteric Tube Positioning AI Algorithm is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253502.

When did Critical Care Suite with Enteric Tube Positioning AI Algorithm receive FDA 510(k) clearance?

Critical Care Suite with Enteric Tube Positioning AI Algorithm received FDA 510(k) clearance on 2026-04-14, under 510(k) number K253502.

Who is the listed applicant for Critical Care Suite with Enteric Tube Positioning AI Algorithm?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Critical Care Suite with Enteric Tube Positioning AI Algorithm?

The FDA product code for Critical Care Suite with Enteric Tube Positioning AI Algorithm is QIH.

其他以 Ge Medical Systems, LLC 為申請人之記錄

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。

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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

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