FDA 510(k)

AVIEW

K 號：K214036 · 2022-12-23

決定日期2022-12-23

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

AVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K214036. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AVIEW?

AVIEW is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K214036.

When did AVIEW receive FDA 510(k) clearance?

AVIEW received FDA 510(k) clearance on 2022-12-23, under 510(k) number K214036.

Who is the listed applicant for AVIEW?

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

What is the FDA product code for AVIEW?

The FDA product code for AVIEW is QIH.

其他以 Coreline Soft Co., Ltd. 為申請人之記錄

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相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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