FDA 510(k)

DRX-Rise 移动X射线系统

K号: K213568 · 2022-03-23

决定日期2022-03-23

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

DRX-Rise Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K213568. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DRX-Rise Mobile X-ray System?

DRX-Rise Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Carestream Health. The 510(k) number is K213568.

When did DRX-Rise Mobile X-ray System receive FDA 510(k) clearance?

DRX-Rise Mobile X-ray System received FDA 510(k) clearance on 2022-03-23, under 510(k) number K213568.

Who is the listed applicant for DRX-Rise Mobile X-ray System?

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 DRX-Rise Mobile X-ray System?

The FDA product code for DRX-Rise Mobile X-ray System is IZL.

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 K203159Lux 35 探测器 K163157SmartGrid

官方来源

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