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510(k) K192317

Planmed Clarity 2D and Clarity S by Planmed OY — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2020
Date Received
August 26, 2019
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 Planmed OY

  • K250318 — Planmed XFI (September 26, 2025)
  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K213278 — Planmed Verity (April 28, 2022)
  • K180918 — Planmed Verity (November 30, 2018)
  • K163328 — Planmed Clarity (December 28, 2017)
  • K143435 — Planmed Verity (May 14, 2015)
  • K121418 — PLANMED VERITY (February 1, 2013)
  • K121963 — PLANMED NUANCE DIGIGUIDE (November 21, 2012)
  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)
  • K021945 — PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (February 21, 2003)

Other clearances for product code MUE

  • K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (March 24, 2026)
  • 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)