数字诊断移动X射线系统
K号: K181626 · 2018-07-20
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器械摘要
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 2018-07-20 under 510(k) number K181626. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
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 2018-07-20. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K181626.
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 2018-07-20, under 510(k) number K181626.
Who is the listed applicant for Digital Diagnostic Mobile X-ray System?
FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Samsung Electronics Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：IZL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058便携式DR成像系统Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO 移动X光系统（型号：RAYMO）DRGEM CorporationK253185Lux HD 探测器，DRX-LC 探测器，DRX-Revolution 移动X射线系统Carestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F（AirRay-mini）Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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