# K090268: Shimadzu Mobile X-Ray System Mobile Art Evolution

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Jun 30, 2009 after 147 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 28, 2011 · Class II · Z-0264-2013: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m)

Source page: https://510kreport.com/device/K090268
Methodology: https://510kreport.com/methodology