AIE REGION OF INTEREST IMAGE ENHANCEMENT— 510(k) K062059

Substantially Equivalent

Advanced Image Enhancement

FDA 510(k) clearance K062059 for AIE REGION OF INTEREST IMAGE ENHANCEMENT, Substantially Equivalent on 2006-09-06. Applicant: Advanced Image Enhancement.

Clearance details

Applicant: Advanced Image Enhancement
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-07-20
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, 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.