FDA 510(k)

EFAI 胸套XR 胸腔積液評估系統

K 號：K222076 · 2022-09-08

決定日期2022-09-08

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

EFAI ChestSuite XR Pleural Effusion 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 2022-09-08 under 510(k) number K222076. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EFAI ChestSuite XR Pleural Effusion Assessment System?

EFAI ChestSuite XR Pleural Effusion Assessment System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K222076.

When did EFAI ChestSuite XR Pleural Effusion Assessment System receive FDA 510(k) clearance?

EFAI ChestSuite XR Pleural Effusion Assessment System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K222076.

Who is the listed applicant for EFAI ChestSuite XR Pleural Effusion 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 ChestSuite XR Pleural Effusion Assessment System?

The FDA product code for EFAI ChestSuite XR Pleural Effusion Assessment System is QFM.

其他以 Ever Fortune.Ai, Co., Ltd. 為申請人之記錄

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相關器械（代碼：QFM）

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。

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482科格奈特AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-Ai K243808Rayvolve PTX-PE 医療設備規範文本 Rayvolve PTX-PE 医療器材規範文本AZmed K243548簡易病例分類Aidoc Medical , Ltd.

官方來源

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