# K162529: DigiX FDX

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Medical Systems Limited
- Decided: Mar 3, 2017 after 175 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: 11 generations back to K801623 (1980). 112 ancestors in all.
6 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)
- K081722: YSIO, Siemens Medical Solutions USA, Inc. (2008) Summary page 4.
- K130318: Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB), Varian Medical Systems, X-Ray Products-Infimed (2013) Summary page 5.
- K142698: PerkinElmer, XRpad 4343 F MED Flat Panel Detector, Perkinelmer, Inc. (2014) Summary page 5.
- K142049: Multix Fusion VA30 & VA40, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K140551: Perkinelmer, Xrpad 4336 Med Flat Panel Detector, Perkinelmer, Inc. (2014) Summary page 5.
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T, Sedecal., Sa. (2013) Summary page 5.
- K093066: I5 Digital X-Ray Imaging System, Model I5, Infimed, Inc. (2010) Summary page 11.
- K140825: Delworks DR System, Del Medical, Inc. (2014) Summary page 13.

## Most influential descendants
- K192541: DigiX FDX (2019), 5 descendants of its own
- K223060: DigiX FDX (2022), 4 descendants of its own
- 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

## 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 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/K162529
Methodology: https://510kreport.com/methodology