VixWin Platinum— 510(k) K141451

Substantially Equivalent

Imaging Sciences International (Dba Gendex, LLC)

FDA 510(k) clearance K141451 for VixWin Platinum, Substantially Equivalent on 2014-08-26. Applicant: Imaging Sciences International (Dba Gendex, LLC).

Clearance details

Applicant: Imaging Sciences International (Dba Gendex, LLC)
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-06-02
Decision date: 2014-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.