# K063262: AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Imaging
- Decided: Dec 26, 2006 after 57 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: 5 generations back to K981556 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021016: Amx-4 Plus Mobile X-Ray System, GE Medical Systems (2002) Summary page 1.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003)
- K043002: Sedecal Mobile X-Ray Units with Digital Detector, Sedecal., Sa. (2004) Summary page 1.

## Indications for use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K063262
Methodology: https://510kreport.com/methodology