# K223060: DigiX FDX

- Pathway: 510(k) (Special)
- Applicant: Allengers Medical Systems Limited
- Decided: Oct 26, 2022 after 26 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: 13 generations back to K801623 (1980). 114 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192541: DigiX FDX, Allengers Medical Systems Limited (2019) Summary page 4.
- K081722: YSIO, Siemens Medical Solutions USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own
- K263033: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (2026), 0 descendants of its own
- K261748: Dental Cone-beam Computed Tomography (mDX-15P Series) (2026), 0 descendants of its own

## Indications for use
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient’s sitting, standing, or in the prone/supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

Source page: https://510kreport.com/device/K223060
Methodology: https://510kreport.com/methodology