FDA 510(k)

PRORAD X射线平板探测器带DROC

K号: K240771 · 2024-11-12

申请人Prognosys Medical Systems Private Limited

决定日期2024-11-12

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

PRORAD X-Ray Flat Panel Detector with DROC is the device name listed in this FDA 510(k) record. The listed applicant is Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K240771. 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 PRORAD X-Ray Flat Panel Detector with DROC?

PRORAD X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K240771.

When did PRORAD X-Ray Flat Panel Detector with DROC receive FDA 510(k) clearance?

PRORAD X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2024-11-12, under 510(k) number K240771.

Who is the listed applicant for PRORAD X-Ray Flat Panel Detector with DROC?

The FDA 510(k) record lists Prognosys Medical Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRORAD X-Ray Flat Panel Detector with DROC?

The FDA product code for PRORAD X-Ray Flat Panel Detector with DROC is MQB.

列明Prognosys Medical Systems Private Limited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。

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