OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM— 510(k) K071015
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K071015 for OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM, Substantially Equivalent on 2007-05-10. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Malvern, PA, 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.