# K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T

- Pathway: 510(k) (Traditional)
- Applicant: Sedecal., Sa.
- Decided: Apr 18, 2013 after 20 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
Longest line of descent: 8 generations back to K896095 (1990). 29 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112527: Universal Digital Interface (Udi) 1717, Meridian Medical Systems, LLC (2012) Summary page 1.
- K111305: Universal Digital Interface Wireless - Udi 1417W, Meridian Medical Systems, LLC (2012) Summary page 1.
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System, Medicatech USA (2011) Summary page 1.

## Most influential descendants
- 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
- K230985: Planmeca Viso (2023), 3 descendants of its own

## Indications for use
Sedlecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenflm systems may be used, excluding fluoroscopy. angiography and mammography. The kit allows imaging of the skull, chest, shoulders. spine, abdomen, pelvis, and extremities.

Source page: https://510kreport.com/device/K130883
Methodology: https://510kreport.com/methodology