510(k) · Cleared
Recalled · Class II · 2011Shimadzu Mobile X-Ray System Mux-100D Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · IZL System, X-Ray, Mobile
Cleared on Jul 13, 2004 after a 13-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 42 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 1
- Predicates
- 0
42 later devices descend from it, 1 citing it directly.
- This deviceK041763 Shimadzu Mobile X-Ray System Mux-100D SeriesShimadzu Corp. · 2004
- Descendant · cites it directly · 41 of its ownK120062 DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 25 of its ownK123526 Clearread +ConfirmRiverain Technologies · 2012
- Descendant · 3 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 4 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 5 generations on · 19 of its ownK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K120062DRX-Revolution Mobile X-Ray SystemCarestream Health, Inc. · 2012 · cites it directly41descendants
- K123526Clearread +ConfirmRiverain Technologies · 2012 · 2 generations on25descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 3 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 4 generations on22descendants
- K173828GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041763 | Shimadzu Mobile X-Ray System Mux-100D Series | Shimadzu Corp. | 2004 | — |
| +1 | K120062 | DRX-Revolution Mobile X-Ray System | Carestream Health, Inc. | 2012 | 7 |
| +2 | K123526 | Clearread +Confirm | Riverain Technologies | 2012 | — |
| +3 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +4 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| +5 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120062 | DRX-Revolution Mobile X-Ray System | 2012 | 41 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2011 | Class II | Z-0263-2013 | Nonconforming Material/Component | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120062 (Carestream Health, Inc., 2012) has gone furthest, with 41 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 | — |
What is it indicated for?
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
Exposure can be captured on film, CR or Digital Radiography (DR)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041763: Shimadzu Mobile X-Ray System Mux-100D Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041763
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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