XyCAM RI，XyCAM RI 系统，XyCAM 视网膜成像系统
K号: K193319 · 2020-06-01
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决定日期2020-06-01
产品代码HKI
咨询委员会OP
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决定实质等同
器械摘要
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Vasoptic Medical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193319. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Vasoptic Medical, Inc.. The 510(k) number is K193319.
When did XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System receive FDA 510(k) clearance?
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193319.
Who is the listed applicant for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?
The FDA 510(k) record lists Vasoptic Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?
The FDA product code for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is HKI.
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。
相关器械（代码：HKI）
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。
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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