FDA 510(k)

SCENARIA 觀察

K 號：K190841 · 2019-09-13

決定日期2019-09-13

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

SCENARIA View is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K190841. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SCENARIA View?

SCENARIA View is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K190841.

When did SCENARIA View receive FDA 510(k) clearance?

SCENARIA View received FDA 510(k) clearance on 2019-09-13, under 510(k) number K190841.

Who is the listed applicant for SCENARIA View?

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

What is the FDA product code for SCENARIA View?

The FDA product code for SCENARIA View is JAK.

其他以 Hitachi Healthcare Americas 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。

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相關器械（代碼：JAK）

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。

K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm Corporation K253836FCT iStream 階段 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770卡迪克套件GE Medical Systems SCS K253560強化版PCCT邊界Ge Medical Systems, LLC

官方來源

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