ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K132654

Substantially Equivalent

Siemens 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.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Gro
Product code: Code IYO
Advisory panel: Radiology
Date received: 2013-08-26
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moutain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.