# K010304: MXR-2000 Mobile X-Ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Irom Imaging, Inc.
- Decided: Feb 12, 2001 after 11 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
No predicates in its family tree.
54 later devices descend from it; 1 cites it directly.
0 of 55 devices 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.

## Most influential descendants
- K012663: Easy Moving  Mobile X-Ray Unit (Model SM-HF) (2001), 53 descendants of its own
- K043002: Sedecal Mobile X-Ray Units with Digital Detector (2004), 52 descendants of its own
- K090322: Easy Moving Plus, SM-XXHF-YY (2009), 50 descendants of its own
- K142492: GM60A-32S, GM60A-40S (2014), 25 descendants of its own
- K150097: GM60A-32S & GM60A-40S (2015), 24 descendants of its own

Source page: https://510kreport.com/device/K010304
Methodology: https://510kreport.com/methodology