510(k) · Cleared
Recalled · Class II · 2026Rover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-X Limited · IZL System, X-Ray, Mobile
Cleared on May 21, 2021 as substantially equivalent to K201488 (Micro-X, Ltd., 2020) after a 14-day review. Its family tree reaches back 5 generations to 2004. It has been recalled 10 times.
- Decided
- May 21, 2021
- Review
- 14 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 5 generations to K041763 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004 · Recalled
- 4 generations backK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · Recalled
- 3 generations backK170755 DRX-Revolution Nano Mobile X-ray SystemCarestream Health, Inc. · 2017
- 2 generations backK173924 DRX-Revolution Nano Mobile X-ray SystemCarestream Health, Inc. · 2018
- 1 generation backK201488 RoverMicro-X, Ltd. · 2020
- This deviceK211423 RoverMicro-X Limited · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | 1 |
| −4 | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | 7 |
| −3 | K170755 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2017 | — |
| −2 | K173924 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2018 | — |
| −1 | K201488 | Rover | Micro-X, Ltd. | 2020 | — |
| 0 (this device) | K211423 | Rover | Micro-X Limited | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201488 | RoverSummary page 4…ile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System 2) Equivalent legally marketed device: K201488, Micro-X Limited Trade/Device Name: Rover Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Reg… | 2020 |
| † | K142003 | FDR D-Evo II Flat Panel Detector System | 2014 |
| † | K192932 | FDR D-EVO III flat panel detector system | 2019 |
| † | K170451 | FDX Console (DR-ID300CL) Software | 2017 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2026 | Class II | Z-1918-2026 | Component design/selection | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| Apr 4, 2025 | Class II | Z-1670-2025 | Device Design | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| Apr 4, 2025 | Class II | Z-1669-2025 | Device Design | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| Mar 28, 2025 | Class II | Z-1579-2025 | Device Design | 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 | Device Design | 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 | Device Design | 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 be activated for a very short time such… |
| Oct 22, 2024 | Class II | Z-0580-2025 | Environmental control | 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 106 kPa(70kPa to 106kPa)… |
| Nov 28, 2023 | Class II | Z-0665-2025 | Device Design | 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 | Software design | 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 started. |
| Aug 31, 2022 | Class II | Z-1786-2022 | Process control | 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 decisions |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211423: Rover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211423
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026