MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM— 510(k) K071036
Substantially EquivalentSiemens Medical Solutions USA, Inc., Ultrasound DI
FDA 510(k) clearance K071036 for MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM, Substantially Equivalent on 2007-05-16. Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.