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510(k) K160579

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software by Rayence Co., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2016
Date Received
March 1, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Rayence Co., Ltd.

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  • 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)

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  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)