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510(k) K202902

2430MCA with Xmaru W by Rayence Co., Ltd. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2021
Date Received
September 29, 2020
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 Rayence Co., Ltd.

  • K243849 — 2430TCA with Xmaru W (March 12, 2025)
  • K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (September 9, 2024)
  • K240371 — 0909FCC, 0909FCC-HS (March 7, 2024)
  • K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (June 21, 2023)
  • K220689 — Vatech Clismile (May 6, 2022)
  • K212753 — 0909FCB, 1212FCA (October 18, 2021)
  • K210985 — 1717FCC (April 28, 2021)
  • K202722 — 1212FCA (October 26, 2020)
  • K201796 — 1717SCV, 1717SGV (July 23, 2020)
  • K190866 — XmaruView V1 (Xmaru Chiroview, Xmaru Podview) (April 30, 2019)

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)