ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System— 510(k) K173981
Substantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Group
FDA 510(k) clearance K173981 for ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System, Substantially Equivalent on 2018-02-02. Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Group.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Group
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Moutain 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.