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510(k) K243849

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
December 16, 2024
Clearance Type
Special
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.

  • 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)
  • K202902 — 2430MCA with Xmaru W (June 21, 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)

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  • 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)