# K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Medical Imaging, LLC
- Decided: Jul 16, 2008 after 106 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904519 (1991). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011486: Q-Rad Radiographic System, Quantum Medical Imaging, LLC (2001) Summary page 1.
- K072010: Quantum Direx System, Quantum Medical Imaging, LLC (2007) Summary page 1.
- K050987: Digital Radiography Model Cxdi-40EG, Canon, Inc. (2005) Summary page 1.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 1.

## Most influential descendants
- K193574: Q-Rad System (2020), 3 descendants of its own
- K201373: DRX-Compass (2020), 2 descendants of its own
- K223842: DRX - Compass (2023), 1 descendant of its own
- K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (2026), 0 descendants of its own

## Indications for use
The Quantum / Canon CXDI Integration System provides diagnostic quality images to aid the physician with diagnosis. The System can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The System is not indicated for use in mammography.

Source page: https://510kreport.com/device/K080905
Methodology: https://510kreport.com/methodology