# K071409: X3C 1590 Digital Radiographic System

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Jun 8, 2007 after 18 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042041 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062405: Xplorer 1590, Imaging Dynamics Company, Ltd. (2006) Summary page 1.
- K042041: Xplorer 1600, Imaging Dynamics Company Limited (2004) Summary page 1.

## Indications for use
The 1590 Digital Radiographic System is integrated into the user’s stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. The 1590 digital radiography system is not to be used for mammography.

Source page: https://510kreport.com/device/K071409
Methodology: https://510kreport.com/methodology