FDA 510(k)

QOCA image智能CXR图像处理系统

K号: K221868 · 2023-01-27

决定日期2023-01-27

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

QOCA image Smart CXR Image Processing 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 2023-01-27 under 510(k) number K221868. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QOCA image Smart CXR Image Processing System?

QOCA image Smart CXR Image Processing System is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K221868.

When did QOCA image Smart CXR Image Processing System receive FDA 510(k) clearance?

QOCA image Smart CXR Image Processing System received FDA 510(k) clearance on 2023-01-27, under 510(k) number K221868.

Who is the listed applicant for QOCA image Smart CXR Image Processing 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 CXR Image Processing System?

The FDA product code for QOCA image Smart CXR Image Processing System is QFM.

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。

K231855QOCA® image智能RT轮廓系统 K210179QOCA便携式心电图监测设备

官方来源

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