510(k) · Cleared
Recalled · Class II · 2023DRX-Revolution Mobile X-ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · IZL System, X-Ray, Mobile
Cleared on May 17, 2019 as substantially equivalent to K120062 (Carestream Health, Inc., 2012) after a 29-day review. Its family tree reaches back 2 generations to 2004. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- May 17, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041763 (2004). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004 · Recalled
- 1 generation backK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · Recalled
- This deviceK191025 DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK241505 DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK222339 uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK253185 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health · 2026
- Descendant · 2 generations on · 0 of its ownK242515 uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK213568 DRX-Rise Mobile X-ray SystemCarestream Health · 2022
Most influential descendants
Showing 5 of 5 · See all- K241505DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · 2024 · cites it directly1descendant
- K222339uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2022 · cites it directly1descendant
- K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health · 2026 · 2 generations on0descendants
- K242515uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. · 2024 · 2 generations on0descendants
- K213568DRX-Rise Mobile X-ray SystemCarestream Health · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | 1 |
| −1 | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | 7 |
| 0 (this device) | K191025 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2019 | — |
| +1 | K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024 | — |
| +1 | K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022 | — |
| +2 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | 2026 | — |
| +2 | K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| +1 | K213568 | DRX-Rise Mobile X-ray System | Carestream Health | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K120062 | DRX-Revolution Mobile X-Ray SystemSummary page 4…ket notification for modifications to the DRX-Revolution Mobile X- ray System. Caresteam believes this modified device is substantially equivalent to the cleared device (K120062). Date Summary Prepared: April 15 2019 Predicate Subjec… | 2012 |
| † | K090318 | Carestream DRX-1 System | 2009 |
| † | K150766 | Carestream DRX-1 System | 2015 |
| † | K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | 2015 |
| † | K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | 2019 |
| † | K163203 | Carestream DRX-Evolution | 2016 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2023 | Class II | Z-0289-2024 | Component design/selection | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload… |
| Oct 2, 2023 | Class II | Z-0437-2024 | Component design/selection | Unexpected failure of electrical components within the CPI generator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K241505 (Carestream Health, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K120062.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 all pediatric and adult patients, in all patient treatment areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191025: DRX-Revolution Mobile X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191025
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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