IGTFusion— 510(k) K180522

Substantially Equivalent

Igi Technologies

FDA 510(k) clearance K180522 for IGTFusion, Substantially Equivalent on 2018-08-16. Applicant: Igi Technologies.

Clearance details

Applicant: Igi Technologies
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-02-27
Decision date: 2018-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: College Park, MD, 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.