# K071402: X3C 1600 Plus Digital Radiographic System

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Jun 8, 2007 after 18 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
Longest line of descent: 1 generation back to K062586 (2006). 1 ancestor in all.
1 later device descends 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)
- K062586: Xplorer 1600 Plus, Imaging Dynamics Company, Ltd. (2006) Summary page 1.

## Most influential descendants
- K111098: Innovaxion FP, Innovaxion FP 1600 Plus, Magellan (2011), 0 descendants of its own

## Indications for use
The X3C 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 positions. The X3C 1600 Plus (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K071402
Methodology: https://510kreport.com/methodology