240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS— 510(k) K003725

Substantially Equivalent

Pie Medical

FDA 510(k) clearance K003725 for 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS, Substantially Equivalent on 2001-03-01. Applicant: Pie Medical.

Clearance details

Applicant: Pie Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2000-12-04
Decision date: 2001-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

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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.