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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K260087

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright · GE Medical Systems SCS · decided 2026-03-24 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Senographe PristinaPOZ2GE MEDICAL SYSTEMSMUE OTE00198953109281