510(k) · Cleared
Recalled · Class II · 2014Mobilette XP and Mobilett Xphybrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · IZL System, X-Ray, Mobile
Cleared on Nov 14, 2003 as substantially equivalent to K932106 (Siemens Medical Solutions USA, Inc., 1994) after a 39-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 14, 2003
- Review
- 39 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932106 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932106 Mobilett Plus Mobile X-Ray SystemSiemens Medical Solutions USA, Inc. · 1994
- This deviceK033238 Mobilette XP and Mobilett XphybridSiemens Medical Systems, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK111912 Mobilett MiraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK193277 SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK241295 SOMATOM On.siteSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK182639 MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K111912Mobilett MiraSiemens Medical Solutions USA, Inc. · 2011 · cites it directly3descendants
- K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on1descendant
- K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc. · 2024 · 3 generations on0descendants
- K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932106 | Mobilett Plus Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | 1994 | — |
| 0 (this device) | K033238 | Mobilette XP and Mobilett Xphybrid | Siemens Medical Systems, Inc. | 2003 | — |
| +1 | K111912 | Mobilett Mira | Siemens Medical Solutions USA, Inc. | 2011 | 5 |
| +2 | K193277 | SOMATOM On.site and On.scene | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +3 | K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +2 | K182639 | MOBILETT Elara Max | Siemens Medi Cal Solutions, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K932106 | Mobilett Plus Mobile X-Ray SystemSummary page 1…IZL 3. Predicate Device Name FDA Clearance Number FDA Clearance Date Siemens Mobilett PludMobilett Plus HP K932 106 09114/94 4. Device Description: The Mobilett XP and Mobilett XPhybfidx-ray systems are microprocess… | 1994 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111912 | Mobilett Mira | 2011 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2014 | Class II | Z-1985-2014 | Component design/selection | There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which… |
| Oct 4, 2010 | Not classified | Z-0171-2011 | Device Design | Units not equipped with protective plastic cover over electronics. |
| Oct 4, 2010 | Not classified | Z-0718-2011 | Other | battery fuse |
| Mar 21, 2007 | Not classified | Z-0749-2007 | Other | Mounting bolts for tank fork assembly and collimator flange may become loose. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K111912 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 3 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?
The Mobilett XP and Mobilett XPhybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033238 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033238: Mobilette XP and Mobilett Xphybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033238
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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