# K220518: Skanrad 400

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Limited
- Decided: Apr 1, 2022 after 37 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: 12 generations back to K981556 (1998). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173517: RADspeed fit, Shimadzu Corporation (2018) Summary page 4.

## Indications for use
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremities and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical personnel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.

Source page: https://510kreport.com/device/K220518
Methodology: https://510kreport.com/methodology