50S TRINGA ULTRASOUND IMAGING SYSTEM— 510(k) K020112

Substantially Equivalent

Pie Medical

FDA 510(k) clearance K020112 for 50S TRINGA ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 2002-04-19. Applicant: Pie Medical.

Clearance details

Applicant: Pie Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2002-01-11
Decision date: 2002-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.