510(k) · Cleared
ClearedMXR-2000 Mobile X-Ray Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irom Imaging, Inc. · IZL System, X-Ray, Mobile
Cleared on Feb 12, 2001 after an 11-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 54 later devices descend from it.
- Decided
- Feb 12, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 1 citing it directly.
- This deviceK010304 MXR-2000 Mobile X-Ray UnitIrom Imaging, Inc. · 2001
- Descendant · cites it directly · 53 of its ownK012663 Easy Moving Mobile X-Ray Unit (Model SM-HF)Sedecal USA, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 52 of its ownK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
- Descendant · 2 generations on · 50 of its ownK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
- Descendant · 3 generations on · 25 of its ownK142492 GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · Recalled
- Descendant · 4 generations on · 24 of its ownK150097 GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K012663Easy Moving Mobile X-Ray Unit (Model SM-HF)Sedecal USA, Inc. · 2001 · cites it directly53descendants
- K043002Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004 · 2 generations on52descendants
- K090322Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · 2 generations on50descendants
- K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · 3 generations on25descendants
- K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010304 | MXR-2000 Mobile X-Ray Unit | Irom Imaging, Inc. | 2001 | — |
| +1 | K012663 | Easy Moving Mobile X-Ray Unit (Model SM-HF) | Sedecal USA, Inc. | 2001 | 1 |
| +2 | K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal., Sa. | 2004 | — |
| +2 | K090322 | Easy Moving Plus, SM-XXHF-YY | Sedecal., Sa. | 2009 | 31 |
| +3 | K142492 | GM60A-32S, GM60A-40S | Samsung Electronics Co., Ltd. | 2014 | 1 |
| +4 | K150097 | GM60A-32S & GM60A-40S | Samsung Electronics Co., Ltd. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012663 | Easy Moving Mobile X-Ray Unit (Model SM-HF) | 2001 | 53 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012663 (Sedecal USA, Inc., 2001) has gone furthest, with 53 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.
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 | — |
https://510kreport.com/device/K010304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010304: MXR-2000 Mobile X-Ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010304
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026