FDA 510(k)

EFAI神經套件CT ICH評估系統

K 號：K231025 · 2023-10-04

決定日期2023-10-04

產品代碼QAS

諮詢委員會RA

決定相當於

器材摘要

EFAI NeuroSuite CT ICH Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) number K231025. 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 EFAI NeuroSuite CT ICH Assessment System?

EFAI NeuroSuite CT ICH Assessment System is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231025.

When did EFAI NeuroSuite CT ICH Assessment System receive FDA 510(k) clearance?

EFAI NeuroSuite CT ICH Assessment System received FDA 510(k) clearance on 2023-10-04, under 510(k) number K231025.

Who is the listed applicant for EFAI NeuroSuite CT ICH Assessment System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI NeuroSuite CT ICH Assessment System?

The FDA product code for EFAI NeuroSuite CT ICH Assessment System is QAS.

其他以 Ever Fortune.Ai, Co., 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。

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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

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