ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS— 510(k) K140959
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K140959 for ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS, Substantially Equivalent on 2014-04-30. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- 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
- Traditional
- Location
- Moutain View, CA, US
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More clearances from Siemens Medical Solutions USA, Inc.
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.