FDA 510(k)

OmniTom Elite 配合 PCD

K 號：K250928 · 2025-09-08

決定日期2025-09-08

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

OmniTom Elite with PCD is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K250928. 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 OmniTom Elite with PCD?

OmniTom Elite with PCD is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Neurologica Corporation. The 510(k) number is K250928.

When did OmniTom Elite with PCD receive FDA 510(k) clearance?

OmniTom Elite with PCD received FDA 510(k) clearance on 2025-09-08, under 510(k) number K250928.

Who is the listed applicant for OmniTom Elite with PCD?

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

What is the FDA product code for OmniTom Elite with PCD?

The FDA product code for OmniTom Elite with PCD is JAK.

其他以 Neurologica Corporation 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。

K233767OmniTom Elite K213649BodyTom 64 K171183OmniTom

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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