# K062586: Xplorer 1600 Plus

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Sep 29, 2006 after 28 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.
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
- K071402: X3C 1600 Plus Digital Radiographic System (2007), 1 descendant of its own
- K111098: Innovaxion FP, Innovaxion FP 1600 Plus, Magellan (2011), 0 descendants of its own

## Indications for use
The Xplorer 1600 Plus 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 posilions. The Xplorer 1600 Pius (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K062586
Methodology: https://510kreport.com/methodology