# K012663: Easy Moving  Mobile X-Ray Unit (Model SM-HF)

- Pathway: 510(k) (Traditional)
- Applicant: Sedecal USA, Inc.
- Decided: Aug 31, 2001 after 18 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
Longest line of descent: 1 generation back to K010304 (2001). 1 ancestor in all.
53 later devices descend from it; 2 cite 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)
- K010304: MXR-2000 Mobile X-Ray Unit, Irom Imaging, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own

## Recalls of this device
- Sep 26, 2002 · Not classified · Z-650/51-03: Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard

## Indications for use
The “Easy Moving™” Mobile X-ray unit (Model SM-HF) is 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/K012663
Methodology: https://510kreport.com/methodology