# K063039: Xplorer 2200 Digital Radiographic System

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Nov 2, 2006 after 30 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K073632: Intuition, Model 0170 (2008), 2 descendants of its own
- K140683: 0180 Intuition, 0072 Precision (2014), 0 descendants of its own
- K121109: Aerodr X70 (2012), 0 descendants of its own
- K071401: X3C 2200 Digital Radiographic  System (2007), 0 descendants of its own

## Indications for use
The Xplorer 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking 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 2200 (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K063039
Methodology: https://510kreport.com/methodology