FDA 510(k)

真視頻處理站

K 號：K253532 · 2025-12-30

決定日期2025-12-30

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

TruSPECT Processing Station is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K253532. 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 TruSPECT Processing Station?

TruSPECT Processing Station is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K253532.

When did TruSPECT Processing Station receive FDA 510(k) clearance?

TruSPECT Processing Station received FDA 510(k) clearance on 2025-12-30, under 510(k) number K253532.

Who is the listed applicant for TruSPECT Processing Station?

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

What is the FDA product code for TruSPECT Processing Station?

The FDA product code for TruSPECT Processing Station is QIH.

其他以 Spectrum Dynamics Medical, 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。

K254001VERITON CT 300系列數位SPECT/CT系統（VERITON CT 316/364）；VERITON CT 400系列數位SPECT/CT系統（VERITON CT 416/464）K230600VERITON CT 300系列數位SPECT/CT系統（VERITON CT 316/364）；VERITON CT 400系列數位SPECT/CT系統（VERITON CT 416/464）K212230TruSPECT 電影學影像處理站 K190457維瑞頓全身SPECT/CT系統 K182484維瑞頓全身SPECT/CT系統 K180514威瑞頓NM

查看所有 8 項裝置 →

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

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。