Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright— 510(k) K260087
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K260087 for Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright, Substantially Equivalent on 2026-03-24. Applicant: GE Medical Systems SCS. Device class: 2.
Summary
GE Medical Systems SCS has four names in this record: Senographe Pristina, SenoBright HD, Pristina Serena and Pristina Serena Bright. They're filed under MUE, full-field digital mammographic x-ray systems.
Class II, 21 CFR 892.1715. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
GE Medical Systems SCS filed from Buc, France. The decision came 71 calendar days after receipt (January 12 to March 24, 2026).
Clearance details
- Applicant
- GE Medical Systems SCS
- Product code
- Product code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buc, FR
Recent devices under product code MUE
view allMore clearances from GE Medical Systems SCS
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.