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. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountainview, CA, US
Recent devices under product code IYO
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view allAdverse 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.