# K072010: Quantum Direx System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Medical Imaging, LLC
- Decided: Aug 7, 2007 after 15 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 K904519 (1991). 13 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 19 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.
- K053634: Computed Radiography System with NX 1.0 Workstation, Agfa Corporation (2006) Summary page 1.
- K063421: DX-SI, Agfa Corp. (2006) Summary page 1.
- K062742: CR 85-X, Agfa Corporation (2006) Summary page 1.
- K062223: Agfa Model CR30-X, Agfa Corporation (2006) Summary page 1.

## Most influential descendants
- K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi (2008), 4 descendants of its own
- 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 DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.

Source page: https://510kreport.com/device/K072010
Methodology: https://510kreport.com/methodology