iQFlex Pro— 510(k) K240009

Substantially Equivalent

First Source, Inc.

FDA 510(k) clearance K240009 for iQFlex Pro, Substantially Equivalent on 2024-07-03. Applicant: First Source, Inc..

Clearance details

Applicant: First Source, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2024-01-02
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.