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)

ERI可攜式X光系統（CVX-air）；ERI可攜式X光系統（CVX-lite）；ERI可攜式X光系統（CVX-E）

K 號：K234108 · 2024-09-20

申請人Energy Resources International Co., Ltd.
決定日期2024-09-20
產品代碼IZL
諮詢委員會RA
決定相當於

器材摘要

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is the device name listed in this FDA 510(k) record. The listed applicant is Energy Resources International Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K234108. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Energy Resources International Co., Ltd.. The 510(k) number is K234108.

When did ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) receive FDA 510(k) clearance?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) received FDA 510(k) clearance on 2024-09-20, under 510(k) number K234108.

Who is the listed applicant for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

The FDA 510(k) record lists Energy Resources International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

The FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is IZL.

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：IZL）

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。

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058攜帶式DR影像系統Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM CorporationK253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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。

↑