DeviceClearance

K260673

Substantially Equivalent

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code
IYN
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN
Death
25
Injury
163
Malfunction
1,538
Other
4
Total
1,730

Source: openFDA MAUDE database, through . 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.