Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
K-Number: K260087 · 2026-03-24
ApplicantGE Medical Systems SCS
Decision Date2026-03-24
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2026-03-24 under approval number K260087. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by GE Medical Systems SCS. The 510(k) number is K260087.
When was Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright approved by the FDA?
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright received FDA 510(k) clearance on 2026-03-24, under approval number K260087.
What company makes Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright?
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright is manufactured by GE Medical Systems SCS.
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.
Other Devices by GE Medical Systems SCS
Related Devices (Code: MUE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.