Xoran Workstation, Model 10050— 510(k) K210257

Substantially Equivalent

Xoran Technologies, LLC

FDA 510(k) clearance K210257 for Xoran Workstation, Model 10050, Substantially Equivalent on 2021-05-20. Applicant: Xoran Technologies, LLC.

Clearance details

Applicant: Xoran Technologies, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-02-01
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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.