# K062417: Xplorer 1100

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Sep 15, 2006 after 28 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K071408: X3C 1100 Radiographic Table with Digital Radiographic Detector (2007), 0 descendants of its own

## Indications for use
The Xplorer 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user’s stalionary radiography system. This typical configuration permits a qualified/trained doctor or technologist o lake a range of head-to-toe diagnoslic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body paris on both adult and pediatric patients. Applications can be performed with patient lying in the prone or supine positions. The Xplorer 1100 (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K062417
Methodology: https://510kreport.com/methodology