510(k) · Cleared
Recalled · Class II · 2023Mobilett Mira
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZL System, X-Ray, Mobile
Cleared on Sep 19, 2011 as substantially equivalent to K033238 (Siemens Medical Systems, Inc., 2003) and 1 other predicate after a 76-day review. Its family tree reaches back 9 generations to 1980. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 19, 2011
- Review
- 76 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 9 generations to K801623 (1980). 66 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK111912 Mobilett MiraSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK193277 SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK241295 SOMATOM On.siteSiemens Medical Solutions USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK182639 MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK111912 Mobilett MiraSiemens Medical Solutions USA, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −1 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| 0 (this device) | K111912 | Mobilett Mira | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K193277 | SOMATOM On.site and On.scene | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +1 | K182639 | MOBILETT Elara Max | Siemens Medi Cal Solutions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K033238 | Mobilette XP and Mobilett XphybridSummary page 2…are sent wireless to the mobile unit. The Mobilett Mira is a modification of the Mobilett XP originally cleared under Premarket Notification K033238 on 11/14/2003. The modification consists of a rotatable suspension arm, a solid state image detector, digital image acqu… | 2003 |
| * | K081722 | YSIOSummary page 2…* X-ray Generator * X-ray tube Ysio K081 722 08/22/2008 * Solid State detector o Imaging system 5… | 2008 |
| * | — | Mobilett XP hybrid Named without a submission number |
What descends from it? (3)
2 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 5, 2023 | Class II | Z-0223-2024 | Nonconforming Material/Component | Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure… |
| May 2, 2013 | Class II | Z-1875-2013 | Device Design | Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is… |
| Oct 10, 2012 | Class II | Z-0480-2013 | Software design | There is a risk of lost images during examination. |
| Aug 21, 2012 | Class II | Z-2322-2012 | Device Design | During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to… |
| Apr 30, 2012 | Class II | Z-2367-2012 | Device Design | During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 66 ancestors have a recall of any class.
- Of its descendants, K193277 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 1 descendant 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. 2011, 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 Mobilett Mira is a radiographic system 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/K111912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111912: Mobilett Mira.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111912
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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