FDA 510(k)

TruSPECT 電影學影像處理站

K 號：K212230 · 2021-08-16

決定日期2021-08-16

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

TruSPECT Radiological Image 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 2021-08-16 under 510(k) number K212230. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TruSPECT Radiological Image Processing Station?

TruSPECT Radiological Image Processing Station is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K212230.

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

TruSPECT Radiological Image Processing Station received FDA 510(k) clearance on 2021-08-16, under 510(k) number K212230.

Who is the listed applicant for TruSPECT Radiological Image 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 Radiological Image Processing Station?

The FDA product code for TruSPECT Radiological Image Processing Station is LLZ.

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。

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相關器械（代碼：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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