100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS— 510(k) K002357

Substantially Equivalent

Pie Medical

FDA 510(k) clearance K002357 for 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS, Substantially Equivalent on 2000-11-09. Applicant: Pie Medical.

Clearance details

Applicant: Pie Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2000-08-02
Decision date: 2000-11-09
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.