Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k) K260087 · GE Medical Systems SCS
510(k) numberK260087
Submission
- Device name
- Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- Applicant
- GE Medical Systems SCS
Buc, FR - Received
- January 12, 2026
- Decision date
- March 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright cleared by the FDA?
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (K260087) received a 510(k) decision of Substantially Equivalent on March 24, 2026, 71 days after the submission was received.
What is the product code of K260087?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.