# K193574: Q-Rad System

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: Jan 22, 2020 after 30 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: 7 generations back to K904519 (1991). 21 ancestors in all.
3 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)
- K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi, Quantum Medical Imaging, LLC (2008) Summary page 4.

## Most influential descendants
- 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 Q-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography

Source page: https://510kreport.com/device/K193574
Methodology: https://510kreport.com/methodology