FDA 510(k)

D-SPECT 扫描儀，D-SPECT L 扫描儀

K 號：K161740 · 2016-11-04

決定日期2016-11-04

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

D-SPECT Scanner, D-SPECT L Scanner 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 2016-11-04 under 510(k) number K161740. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the D-SPECT Scanner, D-SPECT L Scanner?

D-SPECT Scanner, D-SPECT L Scanner is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K161740.

When did D-SPECT Scanner, D-SPECT L Scanner receive FDA 510(k) clearance?

D-SPECT Scanner, D-SPECT L Scanner received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161740.

Who is the listed applicant for D-SPECT Scanner, D-SPECT L Scanner?

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 D-SPECT Scanner, D-SPECT L Scanner?

The FDA product code for D-SPECT Scanner, D-SPECT L Scanner is KPS.

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）K253532真視頻處理站 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

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相關器械（代碼：KPS）

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。

官方來源

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