# K162224: ArtPix Mobile EZ2GO

- Pathway: 510(k) (Special)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Sep 22, 2016 after 45 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: 5 generations back to K931071 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110849: Prestodr 4143, Cmt Medical Technologies, Ltd. (2011) Summary page 4.

## Indications for use
The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position

Source page: https://510kreport.com/device/K162224
Methodology: https://510kreport.com/methodology