ULTRASOUND SCANNER MODEL #1150— 510(k) K900469

Substantially Equivalent

Pie Medical USA BV

FDA 510(k) clearance K900469 for ULTRASOUND SCANNER MODEL #1150, Substantially Equivalent on 1990-07-09. Applicant: Pie Medical USA BV.

Clearance details

Applicant: Pie Medical USA BV
Product code: Code IYO
Advisory panel: Radiology
Date received: 1990-01-31
Decision date: 1990-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neptune Township, NJ, 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.