CS-SERIES-FP WITH 3030+OPTION— 510(k) K121293
Substantially EquivalentOmega Medical Imaging, LLC
FDA 510(k) clearance K121293 for CS-SERIES-FP WITH 3030+OPTION, Substantially Equivalent on 2012-07-26. Applicant: Omega Medical Imaging, LLC.
Clearance details
- Applicant
- Omega Medical Imaging, LLC
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.