FDA 510(k)

CINA-ASPECTS

K 號：K233342 · 2024-03-15

決定日期2024-03-15

產品代碼POK

諮詢委員會RA

決定相當於

器材摘要

CINA-ASPECTS is the device name listed in this FDA 510(k) record. The listed applicant is Avicenna.Ai. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K233342. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CINA-ASPECTS?

CINA-ASPECTS is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Avicenna.Ai. The 510(k) number is K233342.

When did CINA-ASPECTS receive FDA 510(k) clearance?

CINA-ASPECTS received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233342.

Who is the listed applicant for CINA-ASPECTS?

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-ASPECTS?

The FDA product code for CINA-ASPECTS is POK.

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 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。)K210237CINA 胸部 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：POK）

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。

K253884科俄斯DS（3.8）Koios Medical, Inc.K261519Sonio懷疑Sonio K254161自動主動脈瓣膜狭窄軟件（AutoAS）GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K251769RevealAI-肺Precision Medical Ventures, Inc. Dba Revealdx K252294胎兒心超掃描器（v1.2）Brightheart K250221中風感測 ASPECTS 軟體應用程序Circle Cardiovascular Imaging, Inc.

官方來源

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