# K212940: Skanmobile, Skanmobile-Dr

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Limited
- Decided: Mar 4, 2022 after 170 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981556 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182317: AMADEO M-DR mini, AMADEO M-AX mini, Oehm Und Rehbein GmbH (2018) Summary page 5.
- K173299: Dragon X SPSL4HC, Dragon X SPSL8HC, Sedecal., Sa. (2018) Summary page 6.

## Indications for use
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist. SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.

Source page: https://510kreport.com/device/K212940
Methodology: https://510kreport.com/methodology