# K090279: Sedecal, Millennium Plus

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Mar 11, 2009 after 35 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 5 generations back to K981556 (1998). 9 ancestors in all.
17 later devices descend from it; 4 cite 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)
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.
- K062335: Sedecal X Plus LP Plus, Sedecal., Sa. (2006) Summary page 1.

## Most influential descendants
- K133782: Nova FA DR System (2014), 11 descendants of its own
- K173953: uDR 780i (2018), 2 descendants of its own
- K150816: Jumong Series (2015), 2 descendants of its own
- K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (2015), 2 descendants of its own
- K241068: uDR 780i (2024), 1 descendant of its own

## Indications for use
These Digital Radiographic Systems are 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/K090279
Methodology: https://510kreport.com/methodology