FDA 510(k)

光頻納米 Spectra, 光頻納米 Spectra Select

K 號：K253520 · 2026-03-20

決定日期2026-03-20

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Photonova Spectra, Photonova Spectra Select is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253520. 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 Photonova Spectra, Photonova Spectra Select?

Photonova Spectra, Photonova Spectra Select is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253520.

When did Photonova Spectra, Photonova Spectra Select receive FDA 510(k) clearance?

Photonova Spectra, Photonova Spectra Select received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253520.

Who is the listed applicant for Photonova Spectra, Photonova Spectra Select?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photonova Spectra, Photonova Spectra Select?

The FDA product code for Photonova Spectra, Photonova Spectra Select is JAK.

其他以 Ge Medical Systems, LLC 為申請人之記錄

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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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