ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K121646
Substantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Gro
FDA 510(k) clearance K121646 for ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2012-06-22. Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Gro
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Moutain View, CA, US
Recent devices under product code IYN
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More clearances from Siemens Medical Solutions USA, Inc. Ultrasound Gro
view allAdverse 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.