FDA 510(k)

QOCA® image智能RT轮廓系统

K号: K231855 · 2024-02-13

决定日期2024-02-13

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

QOCA® image Smart RT Contouring System is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Computer, Inc.. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K231855. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QOCA® image Smart RT Contouring System?

QOCA® image Smart RT Contouring System is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K231855.

When did QOCA® image Smart RT Contouring System receive FDA 510(k) clearance?

QOCA® image Smart RT Contouring System received FDA 510(k) clearance on 2024-02-13, under 510(k) number K231855.

Who is the listed applicant for QOCA® image Smart RT Contouring System?

The FDA 510(k) record lists Quanta Computer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QOCA® image Smart RT Contouring System?

The FDA product code for QOCA® image Smart RT Contouring System is QKB.

列明Quanta Computer, Inc.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。

K221868QOCA image智能CXR图像处理系统 K210179QOCA便携式心电图监测设备

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。