Xmaru View V1 and Xmaru PACS, Medical Image Processing Software— 510(k) K160579

Name: FDA 510(k) clearance K160579
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K160579 for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software, Substantially Equivalent on 2016-04-08. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2016-03-01
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Rayence Co., Ltd.

view all

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K243849 — 2430TCA with Xmaru W2025-03-12
K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)2024-09-09
K240371 — 0909FCC, 0909FCC-HS2024-03-07
K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF2023-06-21

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.