JADE移动X射线
K号: K183388 · 2019-02-05
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器械摘要
JADE Mobile X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2019-02-05 under 510(k) number K183388. 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 JADE Mobile X-Ray?
JADE Mobile X-Ray is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is DRGEM Corporation. The 510(k) number is K183388.
When did JADE Mobile X-Ray receive FDA 510(k) clearance?
JADE Mobile X-Ray received FDA 510(k) clearance on 2019-02-05, under 510(k) number K183388.
Who is the listed applicant for JADE Mobile X-Ray?
The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for JADE Mobile X-Ray?
The FDA product code for JADE Mobile X-Ray 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DRGEM Corporation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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