SPEQ ULTRASOUND SYSTEM— 510(k) K090505

Substantially Equivalent

Signostics Pty, Ltd.

FDA 510(k) clearance K090505 for SPEQ ULTRASOUND SYSTEM, Substantially Equivalent on 2009-05-07. Applicant: Signostics Pty, Ltd..

Clearance details

Applicant: Signostics Pty, Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2009-02-26
Decision date: 2009-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bainbridge Island, WA, 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.