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FDA 510(k)

VERITON 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）

K号: K230600 · 2023-04-28

申请人Spectrum Dynamics Medical, Ltd.
决定日期2023-04-28
产品代码KPS
咨询委员会RA
决定实质等同

器械摘要

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) 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 2023-04-28 under 510(k) number K230600. 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 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K230600.

When did VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) receive FDA 510(k) clearance?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230600.

Who is the listed applicant for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

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 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

The FDA product code for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is KPS.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 →

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。

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo（uMI Panvivo M）Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 系列Siemens Medical Solutions USA, Inc.K260524uMI Panvivo（uMI Panvivo LS）；uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）Shanghai United Imaging Healthcare Co., Ltd.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）Spectrum Dynamics Medical, Ltd.

官方来源

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