MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A— 510(k) K052164
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K052164 for MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A, Substantially Equivalent on 2005-10-04. 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
- Traditional
- 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.