ArcScan Insight 100
K号: K153416 · 2016-02-02
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器械摘要
ArcScan Insight 100 is the device name listed in this FDA 510(k) record. The listed applicant is Arcscan, Inc.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) number K153416. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ArcScan Insight 100?
ArcScan Insight 100 is a medical device that received FDA 510(k) clearance on 2016-02-02. The listed applicant is Arcscan, Inc.. The 510(k) number is K153416.
When did ArcScan Insight 100 receive FDA 510(k) clearance?
ArcScan Insight 100 received FDA 510(k) clearance on 2016-02-02, under 510(k) number K153416.
Who is the listed applicant for ArcScan Insight 100?
The FDA 510(k) record lists Arcscan, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ArcScan Insight 100?
The FDA product code for ArcScan Insight 100 is IYO.
相关临床试验
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相关器械（代码：IYO）
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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