# K231761: PodSKAN HF Diagnostic X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Limited
- Decided: Oct 27, 2023 after 133 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: 2 generations back to K811230 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160857: HF 718BD X-Ray System, Arquilla, Inc. Dba X-Cel X-Ray Corporation (2017) Summary page 4.

## Indications for use
PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics. PodSKAN is not intended for Mammography and Fluoroscopy Applications.

Source page: https://510kreport.com/device/K231761
Methodology: https://510kreport.com/methodology