SONARA; SONARA/TEK— 510(k) K060421

Substantially Equivalent

Viasys Healthcare, Inc.

FDA 510(k) clearance K060421 for SONARA; SONARA/TEK, Substantially Equivalent on 2006-11-03. Applicant: Viasys Healthcare, Inc..

Clearance details

Applicant: Viasys Healthcare, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2006-02-17
Decision date: 2006-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

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, 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.