K200852

Substantially Equivalent

EchoPAC Software Only, EchoPAC Plug-In

Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code: LLZ
Advisory panel: Radiology
Date received: 2020-03-31
Decision date: 2020-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

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.