Cleared Traditional

Insight Enhanced? DRF (EN-1002-01)

K251650 · Imaging Engineering, LLC · Radiology
Sep 2025
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K251650 is an FDA 510(k) clearance for the Insight Enhanced? DRF (EN-1002-01), a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Imaging Engineering, LLC (Gainesville, US). The FDA issued a Cleared decision on September 16, 2025, 110 days after receiving the submission on May 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K251650 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date September 16, 2025
Days to Decision 110 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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