FDA 510(k)

ProRad 2FC和ProRad 3NC固定式X光摄影系统

K号: K183541 · 2019-01-24

申请人Prognosys Medical Systems Private Limited

决定日期2019-01-24

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems 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 2019-01-24 under 510(k) number K183541. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K183541.

When did ProRad 2FC and ProRad 3NC Stationary Radiographic Systems receive FDA 510(k) clearance?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems received FDA 510(k) clearance on 2019-01-24, under 510(k) number K183541.

Who is the listed applicant for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

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 2FC and ProRad 3NC Stationary Radiographic Systems?

The FDA product code for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is KPR.

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。

K243473PRORAD ATLAS 超便携式；PRORAD ATLAS 超便携式 PLUS K240771PRORAD X射线平板探测器带DROC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。