FDA 510(k)

Senographe Pristina；SenoBright HD；Pristina Serena；Pristina Serena Bright

K号: K260087 · 2026-03-24

决定日期2026-03-24

产品代码MUE

咨询委员会RA

决定实质等同

器械摘要

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K260087. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright?

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is GE Medical Systems SCS. The 510(k) number is K260087.

When did Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright receive FDA 510(k) clearance?

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright received FDA 510(k) clearance on 2026-03-24, under 510(k) number K260087.

Who is the listed applicant for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright?

FDA 510(k)记录列出了GE医疗系统SCS为申请人。这本身并不能确立该设备制造商。

What is the FDA product code for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright?

The FDA product code for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright is MUE.

列明GE Medical Systems SCS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。

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