MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM— 510(k) K081121
Substantially EquivalentSiemens Medical Solutions USA, Inc., Ultrasound DI
FDA 510(k) clearance K081121 for MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM, Substantially Equivalent on 2008-06-04. Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountainview, CA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.