FDA 510(k)

DigiX FDX

K 號：K162529 · 2017-03-03

決定日期2017-03-03

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

DigiX FDX is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162529. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DigiX FDX?

DigiX FDX is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K162529.

When did DigiX FDX receive FDA 510(k) clearance?

DigiX FDX received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162529.

Who is the listed applicant for DigiX FDX?

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

What is the FDA product code for DigiX FDX?

The FDA product code for DigiX FDX is KPR.

其他以 Allengers Medical Systems Limited 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。

K253296數位C-ARM搭配3D K243734無線/有線X光平面探測器 K223009無線/有線X光平面檢測器 K223060DigiX FDX K220311心血管內視鏡攝影系統 K200218數位掃描FDX

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相關器械（代碼：KPR）

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。

K260227EXSYS DEXi (EXSYS DEXi-S40S)；EXSYS DEXi (EXSYS DEXi-S40P)；EXSYS DEXi (EXSYS DEXi-S40T)；EXSYS DEXi (EXSYS DEXi-S50H)DRTECH Corporation K260488MULTIX 震擊；MULTIX 震擊 CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE 雙用設備Jpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus 電影系統，DRX-Compass 流動電影系統，Lux HD 35 探測器，Lux HD 43 探測器Carestream Health

官方來源

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