FDA 510(k)

CINA 胸部

K 號：K210237 · 2021-05-19

決定日期2021-05-19

產品代碼QAS

諮詢委員會RA

決定相當於

器材摘要

CINA CHEST is the device name listed in this FDA 510(k) record. The listed applicant is Avicenna.Ai. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K210237. 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 CINA CHEST?

CINA CHEST is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Avicenna.Ai. The 510(k) number is K210237.

When did CINA CHEST receive FDA 510(k) clearance?

CINA CHEST received FDA 510(k) clearance on 2021-05-19, under 510(k) number K210237.

Who is the listed applicant for CINA CHEST?

The FDA 510(k) record lists Avicenna.Ai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CINA CHEST?

The FDA product code for CINA CHEST is QAS.

其他以 Avicenna.Ai 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。

K240942CINA-C脊椎 K240612CINA-VCF K233342CINA-ASPECTS K233968CINA-iPE K221716CINA (注意：原文中未提供具体的医疗设备名称或相关文本，因此无法进行翻译。请提供具体的文本内容以便进行翻译。)K200855CINA (注意：原文中未提供具体的医疗设备名称或相关文本，因此无法进行翻译。请提供具体的文本内容以便进行翻译。)

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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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