FDA 510(k)

SpotLight CT

K号: K161066 · 2016-08-10

决定日期2016-08-10

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

SpotLight CT is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161066. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpotLight CT?

SpotLight CT is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Arineta , Ltd.. The 510(k) number is K161066.

When did SpotLight CT receive FDA 510(k) clearance?

SpotLight CT received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161066.

Who is the listed applicant for SpotLight CT?

The FDA 510(k) record lists Arineta , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpotLight CT?

The FDA product code for SpotLight CT is JAK.

列明Arineta , Ltd.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。

K250650SpotLight / SpotLight Duo带低剂量肺癌筛查选项 K241200SpotLight/SpotLight Duo带低剂量肺癌筛查选项 K230370SpotLight/SpotLight Duo（带DLIR选项）K213465CardioGraphe

官方来源

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