Insight Enhanced DRF (EN-1002-01)— 510(k) K251650

Substantially Equivalent

Imaging Engineering, LLC

FDA 510(k) clearance K251650 for Insight Enhanced DRF (EN-1002-01), Substantially Equivalent on 2025-09-16. Applicant: Imaging Engineering, LLC.

Clearance details

Applicant: Imaging Engineering, LLC
Product code: Code JAA
Advisory panel: Radiology
Date received: 2025-05-29
Decision date: 2025-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.