FDA 510(k)

Lux HD 探测器，DRX-LC 探测器，DRX-Revolution 移动X射线系统

K号: K253185 · 2026-03-11

决定日期2026-03-11

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

Lux HD Detectors, DRX-LC Detector, DRX-Revolution 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 2026-03-11 under 510(k) number K253185. 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 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Carestream Health. The 510(k) number is K253185.

When did Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System receive FDA 510(k) clearance?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System received FDA 510(k) clearance on 2026-03-11, under 510(k) number K253185.

Who is the listed applicant for Lux HD Detectors, DRX-LC Detector, DRX-Revolution 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 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

The FDA product code for Lux HD Detectors, DRX-LC Detector, DRX-Revolution 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。

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 K163157SmartGrid

官方来源

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