VISITRAK, VERSION 1, RELEASE 1— 510(k) K050372

Substantially Equivalent

Math Resolutions, LLC

FDA 510(k) clearance K050372 for VISITRAK, VERSION 1, RELEASE 1, Substantially Equivalent on 2005-03-25. Applicant: Math Resolutions, LLC.

Clearance details

Applicant: Math Resolutions, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2005-02-14
Decision date: 2005-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.