# K043002: Sedecal Mobile X-Ray Units with Digital Detector

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Nov 18, 2004 after 17 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: 4 generations back to K981556 (1998). 7 ancestors in all.
52 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012663: Easy Moving  Mobile X-Ray Unit (Model SM-HF), Sedecal USA, Inc. (2001) Summary page 1.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K171119: GM85 (2017), 22 descendants of its own

## Indications for use
The Sedecal Mobile Radiographic Systems with Digital Detector are 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/K043002
Methodology: https://510kreport.com/methodology