Galaxy R 数字X光升级
K号: K172435 · 2017-10-13
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器械摘要
Galaxy R Digital Radiography Upgrade is the device name listed in this FDA 510(k) record. The listed applicant is Medien International Co, Ltd.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K172435. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Galaxy R Digital Radiography Upgrade?
Galaxy R Digital Radiography Upgrade is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Medien International Co, Ltd.. The 510(k) number is K172435.
When did Galaxy R Digital Radiography Upgrade receive FDA 510(k) clearance?
Galaxy R Digital Radiography Upgrade received FDA 510(k) clearance on 2017-10-13, under 510(k) number K172435.
Who is the listed applicant for Galaxy R Digital Radiography Upgrade?
The FDA 510(k) record lists Medien International Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Galaxy R Digital Radiography Upgrade?
The FDA product code for Galaxy R Digital Radiography Upgrade is MQB.
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相关器械（代码：MQB）
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。
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官方来源
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