GE LOGIQ 700— 510(k) K001016

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K001016 for GE LOGIQ 700, Substantially Equivalent on 2000-04-24. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code ITX
Advisory panel: Radiology
Date received: 2000-03-29
Decision date: 2000-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.