FDA 510(k)

Annalise Enterprise CTB Triage Trauma

K 號：K231767 · 2023-09-22

決定日期2023-09-22

產品代碼QAS

諮詢委員會RA

決定相當於

器材摘要

Annalise Enterprise CTB Triage Trauma is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231767. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Annalise Enterprise CTB Triage Trauma?

Annalise Enterprise CTB Triage Trauma is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K231767.

When did Annalise Enterprise CTB Triage Trauma receive FDA 510(k) clearance?

Annalise Enterprise CTB Triage Trauma received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231767.

Who is the listed applicant for Annalise Enterprise CTB Triage Trauma?

The FDA 510(k) record lists Annalise-Ai Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annalise Enterprise CTB Triage Trauma?

The FDA product code for Annalise Enterprise CTB Triage Trauma is QAS.

其他以 Annalise-Ai Pty , Ltd. 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。

K231384Annalise Enterprise CTB Triage Trauma K231094Annalise Enterprise CTB Triage-OH K223240Annalise Enterprise CTB Triage Trauma K222179Annalise Enterprise CXR Triage Trauma K222268Annalise Enterprise CXR Triage Trauma

相關器械（代碼：QAS）

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。

K260906a2z-Abdo-分類評估A2z Radiology Ai, Inc.K261085快速血管阻塞（快速VO）iSchemaview K260729血管輔助阻斷分類（VAOT）（v1.0）GuideAI Health K261317簡易病例分類Aidoc Medical , Ltd.K253163EFAI ERSUITE CT 腹膜炎評估系統 (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.

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。