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510(k) K260087

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright by GE Medical Systems SCS — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2026
Date Received
January 12, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

Other clearances by GE Medical Systems SCS

  • K251199 — Allia Moveo (December 9, 2025)
  • K243672 — CardIQ Suite (June 18, 2025)
  • K243651 — VersaViewer (April 21, 2025)
  • K243446 — 3DXR (February 25, 2025)
  • K233731 — CardIQ Suite (August 1, 2024)
  • K233714 — BreView (January 25, 2024)
  • K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (October 11, 2023)
  • K223424 — Spine Auto Views (July 13, 2023)
  • K223490 — FlightPlan for Embolization (March 21, 2023)
  • K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2 (November 22, 2022)

Other clearances for product code MUE

  • K243420 — HESTIA (July 17, 2025)
  • K243849 — 2430TCA with Xmaru W (March 12, 2025)
  • K241113 — VIVIX-M (January 16, 2025)
  • K233539 — MAMMOMAT B.brilliant (March 27, 2024)
  • K220073 — RMF-2000 (January 26, 2023)
  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K212873 — Aspire Cristalle (May 27, 2022)
  • K210151 — Digimamo D (March 1, 2022)
  • K202822 — Helianthus (December 15, 2021)
  • K211725 — Senographe Pristina (August 6, 2021)