LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6— 510(k) K160277
Substantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnostics
FDA 510(k) clearance K160277 for LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6, Substantially Equivalent on 2016-03-25. Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics.
Clearance details
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
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.