Home / 510(k) Clearances / K190866

510(k) K190866

XmaruView V1 (Xmaru Chiroview, Xmaru Podview) by Rayence Co., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2019
Date Received
April 3, 2019
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.

  • 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)
  • K202902 — 2430MCA with Xmaru W (June 21, 2021)
  • K210985 — 1717FCC (April 28, 2021)
  • K202722 — 1212FCA (October 26, 2020)
  • K201796 — 1717SCV, 1717SGV (July 23, 2020)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • 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)