# K200396: Insight Enhanced DRF Digital Imaging System

- Pathway: 510(k) (Special)
- Applicant: Imaging Engineering, LLC
- Decided: Mar 6, 2020 after 17 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: 4 generations back to K911454 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191310: Insight Essentials DRF Digital Imaging System, Imaging Engineering, LLC (2019) Summary page 4.

## Most influential descendants
- K251650: Insight Enhanced™ DRF (EN-1002-01) (2025), 0 descendants of its own

## Indications for use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

Source page: https://510kreport.com/device/K200396
Methodology: https://510kreport.com/methodology