ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K132654
Substantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Gro
FDA 510(k) clearance K132654 for ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2013-09-26. Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Gro
- 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
- Moutain View, CA, US
Recent devices under product code IYO
view allMore clearances from Siemens Medical Solutions USA, Inc. Ultrasound Gro
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.