SuniIQ Digital Radiography System
K号: K162585 · 2016-11-04
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决定日期2016-11-04
产品代码MUH
咨询委员会DE
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器械摘要
SuniIQ Digital Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162585. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SuniIQ Digital Radiography System?
SuniIQ Digital Radiography System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Suni Medical Imaging, Inc.. The 510(k) number is K162585.
When did SuniIQ Digital Radiography System receive FDA 510(k) clearance?
SuniIQ Digital Radiography System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162585.
Who is the listed applicant for SuniIQ Digital Radiography System?
The FDA 510(k) record lists Suni Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SuniIQ Digital Radiography System?
The FDA product code for SuniIQ Digital Radiography System is MUH.
相关临床试验
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相关器械（代码：MUH）
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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