FDA 510(k)

DRX-革命型移動X光系統

K 號：K191025 · 2019-05-17

決定日期2019-05-17

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

DRX-Revolution Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K191025. 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 DRX-Revolution Mobile X-ray System?

DRX-Revolution Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Carestream Health, Inc.. The 510(k) number is K191025.

When did DRX-Revolution Mobile X-ray System receive FDA 510(k) clearance?

DRX-Revolution Mobile X-ray System received FDA 510(k) clearance on 2019-05-17, under 510(k) number K191025.

Who is the listed applicant for DRX-Revolution Mobile X-ray System?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRX-Revolution Mobile X-ray System?

The FDA product code for DRX-Revolution Mobile X-ray System is IZL.

其他以 Carestream Health, Inc. 為申請人之記錄

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K251168影像套件 K241505DRX-革命型移動X光系統 K233381DRX-Evolution Plus 系統 K223842DRX - 磁羅盤 K213307Eclipse II 智能噪音消除器 K202441Eclipse II 智能噪音消除器

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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 Corporation K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

官方來源

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