# K063246: Xplorer 1500 Digital Radiographic System with Stand

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Nov 22, 2006 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Xplorer 1500 Digital Radiographic System with stand (510k submission device) 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 patient sitting or standing. The Xplorer 1500 (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K063246
Methodology: https://510kreport.com/methodology