# K211423: Rover

- Pathway: 510(k) (Special)
- Applicant: Micro-X Limited
- Decided: May 21, 2021 after 14 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K041763 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201488: Rover, Micro-X, Ltd. (2020) Summary page 4.

## Recalls of this device
- Mar 27, 2026 · Class II · Z-1918-2026: X-Ray generator may malfunction resulting in the X-Ray being inoperable.
- Apr 4, 2025 · Class II · Z-1670-2025: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Apr 4, 2025 · Class II · Z-1669-2025: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Mar 28, 2025 · Class II · Z-1579-2025: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- Mar 28, 2025 · Class II · Z-1578-2025: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- Oct 23, 2024 · Class II · Z-0666-2025: During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can b
- Oct 22, 2024 · Class II · Z-0580-2025: Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 1
- Nov 28, 2023 · Class II · Z-0665-2025: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
- May 31, 2023 · Class II · Z-0664-2025: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are s
- Aug 31, 2022 · Class II · Z-1786-2022: Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management

## 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/K211423
Methodology: https://510kreport.com/methodology