# K210469: Insight Agile DRF

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Engineering, LLC
- Decided: Jul 27, 2021 after 161 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: 5 generations back to K973598 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191503: MobileRay Pulse SE Digital Imaging System, Portavision Medical, LLC (2019) Summary page 4.

## Most influential descendants
- K242731: MasteRad MiniX Mobile Digital Imaging System (Mini-X) (2025), 0 descendants of its own

## Indications for use
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)

Source page: https://510kreport.com/device/K210469
Methodology: https://510kreport.com/methodology