# K042041: Xplorer 1600

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Dynamics Company Limited
- Decided: Sep 17, 2004 after 50 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K063039: Xplorer 2200 Digital Radiographic System (2006), 4 descendants of its own
- 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 1600 is intended for use by a qualified/irained doctor or technologist on 1 both adult and pediatric patients for taking diagnoslic radiographic exposures of the skull, spinal column, chest, sbdomen, extremilies, and other body parts but not mammography. Appflcaflons can be performed with patient sitting, standing or lying inthe prone or supine posilions.

Source page: https://510kreport.com/device/K042041
Methodology: https://510kreport.com/methodology