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

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..

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code LLZ
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 ↗

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.