Vivid E80, Vivid E90, Vivid E95— 510(k) K170823
Substantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnostics
FDA 510(k) clearance K170823 for Vivid E80, Vivid E90, Vivid E95, Substantially Equivalent on 2017-06-12. 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.