MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A— 510(k) K133435
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K133435 for MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A, Substantially Equivalent on 2013-12-12. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mavern, PA, US
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.