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510(k) K241113

VIVIX-M by Vieworks Co., Ltd. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2025
Date Received
April 22, 2024
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 Vieworks Co., Ltd.

  • K251410 — VXvue (November 4, 2025)
  • K241125 — VIVIX-S 1751S (November 15, 2024)
  • K220239 — Solid State X-ray Imager(Model: FXRD-4386WB) (September 13, 2022)
  • K221512 — Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) (July 20, 2022)
  • K200418 — VIVIX-S VW (March 18, 2020)
  • K190611 — VIVIX-S 1751S (April 8, 2019)
  • K181003 — VIVIX-S 1717V (May 15, 2018)
  • K163703 — VIVIX-S 1417N (February 8, 2017)
  • K161113 — QXLink (August 5, 2016)
  • K152894 — VIVIX-S 1717N (February 26, 2016)

Other clearances for product code MUE

  • K243420 — HESTIA (July 17, 2025)
  • K243849 — 2430TCA with Xmaru W (March 12, 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)
  • K211215 — SenoBright HD (June 22, 2021)