DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS— 510(k) K093581
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K093581 for DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS, Substantially Equivalent on 2011-04-19. Applicant: Ge Medical Systems, LLC.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.