# K063247: Xplorer 1800 Digital Radiographic System with Universal 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K092307: Imasight 4600 Digital Radiography Sensor (2009), 1 descendant of its own
- K181565: Aquarius 8600 Digital Radiography Sensor (2018), 0 descendants of its own

## Indications for use
The Xplorer 1800 Digital Radiographic System with a universal stand for automatic delector posilioning (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. exlremities, and other body parts on both adult and pediatric palients. Applications can be performed with patient sitling, standing or lying in prone or supine positions. The Xplorer 1800 (530k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K063247
Methodology: https://510kreport.com/methodology