FDA 510(k)

視 ANEURYSM, 視 ANX

K 號：K213319 · 2022-02-18

決定日期2022-02-18

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

Viz ANEURYSM, Viz ANX is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213319. 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 Viz ANEURYSM, Viz ANX?

Viz ANEURYSM, Viz ANX is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K213319.

When did Viz ANEURYSM, Viz ANX receive FDA 510(k) clearance?

Viz ANEURYSM, Viz ANX received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213319.

Who is the listed applicant for Viz ANEURYSM, Viz ANX?

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

What is the FDA product code for Viz ANEURYSM, Viz ANX?

The FDA product code for Viz ANEURYSM, Viz ANX is QFM.

其他以 Viz. Ai, Inc. 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。

K250354Viz Subdural+，Viz SUBDURAL PLUS K232363Viz HDS、Viz Volume Plus、Viz ICH+K223443Viz AAA K223042Viz LVO ContaCT K221100視覺 RV/LV K220439Viz SDH

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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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