FDA 510(k)

SmartGrid

K号: K163157 · 2017-03-21

决定日期2017-03-21

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

SmartGrid is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health. It received FDA 510(k) clearance on 2017-03-21 under 510(k) number K163157. 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 SmartGrid?

SmartGrid is a medical device that received FDA 510(k) clearance on 2017-03-21. The listed applicant is Carestream Health. The 510(k) number is K163157.

When did SmartGrid receive FDA 510(k) clearance?

SmartGrid received FDA 510(k) clearance on 2017-03-21, under 510(k) number K163157.

Who is the listed applicant for SmartGrid?

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

What is the FDA product code for SmartGrid?

The FDA product code for SmartGrid is MQB.

列明Carestream Health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。

K253185Lux HD 探测器，DRX-LC 探测器，DRX-Revolution 移动X射线系统 K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器 K213568DRX-Rise 移动X射线系统 K203159Lux 35 探测器

官方来源

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