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FDA 510(k)

Digital Diagnostic Mobile X-ray System

K 號：K162278 · 2016-11-15

申請人Samsung Electronics Co., Ltd.
決定日期2016-11-15
產品代碼IZL
諮詢委員會RA
決定Substantially Equivalent

器材摘要

Digital Diagnostic Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162278. 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 Digital Diagnostic Mobile X-ray System?

Digital Diagnostic Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K162278.

When did Digital Diagnostic Mobile X-ray System receive FDA 510(k) clearance?

Digital Diagnostic Mobile X-ray System received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162278.

Who is the listed applicant for Digital Diagnostic Mobile X-ray System?

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

What is the FDA product code for Digital Diagnostic Mobile X-ray System?

The FDA product code for Digital Diagnostic Mobile X-ray System is IZL.

相關臨床試驗

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其他以 Samsung Electronics Co., Ltd. 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。

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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.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream 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

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