SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION— 510(k) K032536
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K032536 for SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION, Substantially Equivalent on 2003-11-10. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mavern, PA, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.