# K062405: Xplorer 1590

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Sep 13, 2006 after 29 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071409: X3C 1590 Digital Radiographic System (2007), 0 descendants of its own

## Indications for use
The Xplorer 1580 Digital Radiographic System with motorized stand (510k submission device) is integrated into the user’s slationary 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 patient sitting, standing or lying in the prone or supine positions. The Xplorer 1590 {510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K062405
Methodology: https://510kreport.com/methodology