FDA 510(k)

D-SPECT扫描仪，D-SPECT L扫描仪

K号: K161740 · 2016-11-04

决定日期2016-11-04

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

D-SPECT Scanner, D-SPECT L Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161740. 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 D-SPECT Scanner, D-SPECT L Scanner?

D-SPECT Scanner, D-SPECT L Scanner is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K161740.

When did D-SPECT Scanner, D-SPECT L Scanner receive FDA 510(k) clearance?

D-SPECT Scanner, D-SPECT L Scanner received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161740.

Who is the listed applicant for D-SPECT Scanner, D-SPECT L Scanner?

The FDA 510(k) record lists Spectrum Dynamics Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-SPECT Scanner, D-SPECT L Scanner?

The FDA product code for D-SPECT Scanner, D-SPECT L Scanner is KPS.

列明Spectrum Dynamics Medical, Ltd.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。

K254001VERITON CT 300系列数字SPECT/CT系统（VERITON CT 316/364）；VERITON CT 400系列数字SPECT/CT系统（VERITON CT 416/464）K253532TruSPECT处理站 K230600VERITON CT 300系列数字SPECT/CT系统（VERITON CT 316/364）；VERITON CT 400系列数字SPECT/CT系统（VERITON CT 416/464）K212230TruSPECT 放射影像处理站 K190457威瑞通全身SPECT/CT系统 K182484威瑞通全身SPECT/CT系统

查看所有 8 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。