# K201373: DRX-Compass

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: Jun 26, 2020 after 31 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904519 (1991). 22 ancestors in all.
2 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)
- K193574: Q-Rad System, Carestream Health, Inc. (2020) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Jan 30, 2023 · Class II · Z-1206-2023: After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could

## Indications for use
The device 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 device is not indicated for use in mammography.

Source page: https://510kreport.com/device/K201373
Methodology: https://510kreport.com/methodology