FDA 510(k)

Discovery NM/CT 670 CZT

K号: K153402 · 2016-01-21

决定日期2016-01-21

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Discovery NM/CT 670 CZT is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153402. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Discovery NM/CT 670 CZT?

Discovery NM/CT 670 CZT is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is GE Healthcare. The 510(k) number is K153402.

When did Discovery NM/CT 670 CZT receive FDA 510(k) clearance?

Discovery NM/CT 670 CZT received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153402.

Who is the listed applicant for Discovery NM/CT 670 CZT?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discovery NM/CT 670 CZT?

The FDA product code for Discovery NM/CT 670 CZT is KPS.

列明GE Healthcare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。

K253639查看此医疗设备监管文本： View the medical-device regulatory text for this device_name.K242925MR Contour DL K232346数字专家访问与远程扫描 K223212Precision DL K221680Xeleris V 处理与审查系统 K221932Omni 传奇

查看所有 55 个设备 →

相关器械（代码：KPS）

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。

官方来源

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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。