FDA 510(k)

TruSPECT处理站

K号: K253532 · 2025-12-30

决定日期2025-12-30

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

TruSPECT Processing Station 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 2025-12-30 under 510(k) number K253532. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TruSPECT Processing Station?

TruSPECT Processing Station is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K253532.

When did TruSPECT Processing Station receive FDA 510(k) clearance?

TruSPECT Processing Station received FDA 510(k) clearance on 2025-12-30, under 510(k) number K253532.

Who is the listed applicant for TruSPECT Processing Station?

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 TruSPECT Processing Station?

The FDA product code for TruSPECT Processing Station is QIH.

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）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 K180514维瑞顿NM

查看所有 8 个设备 →

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。