# K041922: GE Tethered Portable Digital Radiographic Detector

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jul 28, 2004 after 12 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: 2 generations back to K862120 (1986). 2 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982196: Digital Radiographic Imaging System, GE Medical Systems (1998) Summary page 1.

## Most influential descendants
- K063283: Definium 5000 X-Ray System (2006), 14 descendants of its own
- 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

## Indications for use
The GE Tethered Portable Digital Radiographic Detector is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammograpohic applications.

Source page: https://510kreport.com/device/K041922
Methodology: https://510kreport.com/methodology