# K170755: DRX-Revolution Nano Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Jun 21, 2017 after 100 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041763 (2004). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120062: DRX-Revolution Mobile X-Ray System, Carestream Health, Inc. (2012) Summary page 4.

## Most influential descendants
- K173924: DRX-Revolution Nano Mobile X-ray System (2018), 2 descendants of its own
- K201488: Rover (2020), 1 descendant of its own
- K211423: Rover (2021), 0 descendants of its own

## Indications for use
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.

Source page: https://510kreport.com/device/K170755
Methodology: https://510kreport.com/methodology