510(k) · Cleared
Recalled · Class II · 2017DRX-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 Apr 13, 2012 as substantially equivalent to K041763 (Shimadzu Corp., 2004) after a 95-day review. Its family tree reaches back 1 generation to 2004. 41 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 13, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041763 (2004). 41 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004 · Recalled
- This deviceK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012
- Descendant · cites it directly · 25 of its ownK123526 Clearread +ConfirmRiverain Technologies · 2012
- Descendant · 2 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 3 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 19 of its ownK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
- Descendant · 4 generations on · 18 of its ownK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K123526Clearread +ConfirmRiverain Technologies · 2012 · cites it directly25descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 2 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 3 generations on22descendants
- K173828GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018 · 4 generations on19descendants
- K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | 1 |
| 0 (this device) | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | — |
| +1 | K123526 | Clearread +Confirm | Riverain Technologies | 2012 | — |
| +2 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +3 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| +4 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
| +4 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K041763 | Shimadzu Mobile X-Ray System Mux-100D SeriesSummary page 1…Shimadzu M obileDaRt Manufactured by Shimadzu Corp. 5 10(k) No. - K041763 (July 13, 2004) Device Description: The DRX-Revolution Mobile X-ray System (also referred to as the DRX-Revolution) is a diagno… | 2004 |
What descends from it? (41)
See all 415 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 |
|---|---|---|---|---|
| May 25, 2017 | Class II | Z-2651-2017 | Process control | Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly. |
| Jan 12, 2017 | Class II | Z-1138-2017 | Device Design | The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator. |
| Nov 25, 2014 | Class II | Z-0800-2015 | Device Design | While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray… |
| Aug 29, 2013 | Class II | Z-0179-2014 | Software design | Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6… |
| Jul 26, 2013 | Class II | Z-0090-2014 | Software design | During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the… |
| Jun 19, 2013 | Class II | Z-0132-2014 | Device Design | Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. |
| Jun 6, 2013 | Class II | Z-0126-2014 | Device Design | Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K123526 (Riverain Technologies, 2012) has gone furthest, with 25 descendants of its own.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/K120062 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120062: DRX-Revolution Mobile X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120062
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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