# K112527: Universal Digital Interface (Udi) 1717

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Medical Systems, LLC
- Decided: May 22, 2012 after 265 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 1717 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 UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17." x 17" sensor plate capture large patient imaging and areas. For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image. The UDI 1717 cannot be used for Mammography applications.

Source page: https://510kreport.com/device/K112527
Methodology: https://510kreport.com/methodology