ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System— 510(k) K152369
Substantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Group
FDA 510(k) clearance K152369 for ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System, Substantially Equivalent on 2015-10-06. 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.