# K111305: Universal Digital Interface Wireless - Udi 1417W

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Medical Systems, LLC
- Decided: Jan 31, 2012 after 267 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T (2013), 11 descendants of its own
- K140825: Delworks DR System (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own
- K223060: DigiX FDX (2022), 4 descendants of its own

## Indications for use
The UDI 1417W System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UD! 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The portable, Wireless 14" x 17° sensor plate captures large patient imaging and areas. The UD! 1417W cannot be used for Mammography applications.

Source page: https://510kreport.com/device/K111305
Methodology: https://510kreport.com/methodology