免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Nexus DRTM數位X光影像系統（配備PaxScan 4336Wv4）

K 號：K161459 · 2016-09-06

申請人Varian Medical Systems, X-Ray Products-Infimed
決定日期2016-09-06
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161459. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. The 510(k) number is K161459.

When did Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) receive FDA 510(k) clearance?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161459.

Who is the listed applicant for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA 510(k) record lists Varian Medical Systems, X-Ray Products-Infimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is MQB.

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

相關器械（代碼：MQB）

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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) LimitedK250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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。

↑