ZED Link— 510(k) K180549

Substantially Equivalent

Zed Technologies

FDA 510(k) clearance K180549 for ZED Link, Substantially Equivalent on 2018-04-12. Applicant: Zed Technologies.

Clearance details

Applicant: Zed Technologies
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-03-01
Decision date: 2018-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Yarra, AU

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.