SONIC WINDOW— 510(k) K140126

Substantially Equivalent

Analogic Corporation

FDA 510(k) clearance K140126 for SONIC WINDOW, Substantially Equivalent on 2014-03-04. Applicant: Analogic Corporation.

Clearance details

Applicant: Analogic Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2014-01-16
Decision date: 2014-03-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Peabody, MA, 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.