# K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Feb 27, 2009 after 25 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). 11 ancestors in all.
46 later devices descend from it; 5 cite it directly.
0 of 58 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.
- K060433: Digital Radiography Cxdi-50C, Canon, Inc. (2006) Summary page 1.
- K031633: Canon Inc., Digital Radiography, Model Cxdi-40C, Canon USA, Inc. (2003) Summary page 1.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 1.
- K023750: Cannon Digital Radiography Model Cxdi-40G, Canon USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K142475: EVS 4343 (2015), 13 descendants of its own
- K192364: GXR-Series Diagnostic X-Ray System (2019), 11 descendants 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/K090238
Methodology: https://510kreport.com/methodology