# K251650: Insight Enhanced™ DRF (EN-1002-01)

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Engineering, LLC
- Decided: Sep 16, 2025 after 110 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K021049 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200396: Insight Enhanced DRF Digital Imaging System, Imaging Engineering, LLC (2020) Summary page 5.
- K132027: Oec 9800 Plus, Ge Oec Medical Systems, Inc. (2014)

## Indications for use
Intended for use by a qualified/trained physician or technician for obtaining fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Rx only.

Source page: https://510kreport.com/device/K251650
Methodology: https://510kreport.com/methodology