# K071403: X3C 1600 Digital Radiographic System

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Jun 11, 2007 after 21 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 K042041 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The 1600 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 but not mammography. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions.

Source page: https://510kreport.com/device/K071403
Methodology: https://510kreport.com/methodology