# K062335: Sedecal X Plus LP Plus

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Sep 14, 2006 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: 2 generations back to K001201 (2000). 2 ancestors in all.
99 later devices descend from it; 5 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012546: Optima Urs Universal Radiographic System, Sedecal USA, Inc. (2001) Summary page 1.

## Most influential descendants
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems (2009), 46 descendants of its own
- K092830: Digital X-Ray Imaging System, Model DRC-1000 (2010), 18 descendants of its own
- K102408: Digital Diagnostic X-Ray System (2010), 17 descendants of its own
- K091090: Digital Flat Panel X-Ray Detector, Model Xmaru 1717 (2010), 17 descendants of its own
- K090279: Sedecal, Millennium Plus (2009), 17 descendants of its own

## Indications for use
The SEDECAL X PLUS LP PLUS Universal 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/K062335
Methodology: https://510kreport.com/methodology