# K972168: Sidexis Digital Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane Co.
- Decided: Sep 5, 1997 after 88 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K992644: Sidexis Digital Radiography Imaging System (1999), 4 descendants of its own
- K013659: Modification to Sidexis Digital Radiography Imaging System (2001), 3 descendants of its own
- K132773: Sidexis 4 (2013), 1 descendant of its own
- K250755: DS Core Diagnosis (2025), 0 descendants of its own
- K081903: Xios Plus Wall-Module (2008), 0 descendants of its own

## Indications for use
The SIDEXIS Digital Radiography System consisting of digital sensor, image processing software, and CRT display is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K972168
Methodology: https://510kreport.com/methodology