FDA 510(k)

光譜CT 7500 RT

K 號：K240844 · 2024-10-18

申請人Philips Medical Systems Technologies , Ltd.

決定日期2024-10-18

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Spectral CT 7500 RT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Technologies , Ltd.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240844. 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 Spectral CT 7500 RT?

Spectral CT 7500 RT is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Philips Medical Systems Technologies , Ltd.. The 510(k) number is K240844.

When did Spectral CT 7500 RT receive FDA 510(k) clearance?

Spectral CT 7500 RT received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240844.

Who is the listed applicant for Spectral CT 7500 RT?

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

What is the FDA product code for Spectral CT 7500 RT?

The FDA product code for Spectral CT 7500 RT is JAK.

其他以 Philips Medical Systems Technologies , Ltd. 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。

K253649光譜CT Verida 系列 K244008光譜CT K173588Illumeo 系統

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。