K260087
- 510(k) number
- K260087
- Device name
- Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- Applicant
- GE Medical Systems SCS FR
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2026-03-24
- Date received
- 2026-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260087.pdf
Official FDA record: K260087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.