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510(k) K254092

Bellalun 2D (VDMS-1000S) by Vieworks Co., Ltd. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
December 19, 2025
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.

  • K260820 — VIVIX-S 4386W (FXRD-4386WA) (June 18, 2026)
  • K251410 — VXvue (November 4, 2025)
  • K241113 — VIVIX-M (January 16, 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)

Other clearances for product code MUE

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  • 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)