SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER— 510(k) K081148
Substantially EquivalentSiemens Medical Solutions USA, Inc., Ultrasound DI
FDA 510(k) clearance K081148 for SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER, Substantially Equivalent on 2008-12-22. Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- 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
- Mountain View, CA, US
Recent devices under product code IYO
view allMore clearances from Siemens Medical Solutions USA, Inc., Ultrasound DI
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 →
Recalls naming K081148
K-number listed on FDA's recall record- Z-1063-2015 — ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
- Z-0930-2013 — ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081148.
Data sourced from openFDA. This site is unofficial and independent of the FDA.