BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX— 510(k) K103476
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K103476 for BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX, Substantially Equivalent on 2011-06-16. Applicant: Ge Medical Systems, LLC.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.