MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea— 510(k) K203443
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K203443 for MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea, Substantially Equivalent on 2021-03-31. 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
- Malvern, 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.