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

Name: FDA 510(k) clearance K251650
Creator: U.S. Food and Drug Administration
Published: 2025-09-16

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. Device class: 2.

Clearance details

Applicant: Imaging Engineering, LLC
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
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 ↗

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More clearances from Imaging Engineering, LLC

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K210469 — Insight Agile DRF2021-07-27
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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.