# K063283: Definium 5000 X-Ray System

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Nov 17, 2006 after 18 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981556 (1998). 12 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062335: Sedecal X Plus LP Plus, Sedecal., Sa. (2006) Summary page 1.
- K041922: GE Tethered Portable Digital Radiographic Detector, General Electric Co. (2004) Summary page 1.
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.

## Most influential descendants
- K122495: Perkinelmer XRD 1622 AP3 Med Flat Panel Detector (2012), 13 descendants of its own
- K140551: Perkinelmer, Xrpad 4336 Med Flat Panel Detector (2014), 12 descendants of its own
- K142698: PerkinElmer, XRpad 4343 F MED Flat Panel Detector (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own

## Recalls of this device
- Mar 24, 2009 · Not classified · Z-1118-2009: A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.
- Dec 17, 2007 · Not classified · Z-1133-2008: GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
- Dec 17, 2007 · Not classified · Z-1134-2008: GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.

## Indications for use
The Definium™ 5000 X-Ray System 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/K063283
Methodology: https://510kreport.com/methodology