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FDA 510(k)

Amrad 医療 AAU 電子射線攝影系統; Amrad 医療 AAU Plus 電子射線攝影系統; Amrad 医療 DFMT 電子射線攝影系統; Amrad 医療 FMT 電子射線攝影系統

K 號：K173823 · 2018-02-09

申請人Summit Industries, LLC
決定日期2018-02-09
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Summit Industries, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K173823. 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 Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Summit Industries, LLC. The 510(k) number is K173823.

When did Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System receive FDA 510(k) clearance?

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System received FDA 510(k) clearance on 2018-02-09, under 510(k) number K173823.

Who is the listed applicant for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

The FDA 510(k) record lists Summit Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

The FDA product code for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is KPR.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Summit Industries, LLC 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。

K153119Amrad 医療 OTS 電子射線攝影系統, Amrad 医療 DFMTS 電子射線攝影系統Amrad 医療 FRS 電子射線攝影系統

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 CorporationK260488MULTIX 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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