510(k) · Cleared
ClearedMOBILETT Impact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · IZL System, X-Ray, Mobile
Cleared on Jul 25, 2023 as substantially equivalent to K222951 (Sedecal., Sa., 2022) after a 55-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jul 25, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896095 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK192011 PhoeniXSedecal., Sa. · 2019
- 2 generations backK212291 PhoenixSedecal., Sa. · 2021 · Recalled
- 1 generation backK222951 SM-VSedecal., Sa. · 2022
- This deviceK231577 MOBILETT ImpactSiemens Medical Solutions · 2023
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 8 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 7 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 6 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 5 generations backK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- 4 generations backK161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model…Sedecal., Sa. · 2016 · Recalled
- 3 generations backK192011 PhoeniXSedecal., Sa. · 2019
- 2 generations backK212291 PhoenixSedecal., Sa. · 2021 · Recalled
- 1 generation backK222951 SM-VSedecal., Sa. · 2022
- This deviceK231577 MOBILETT ImpactSiemens Medical Solutions · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −8 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −7 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −6 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −5 | K101517 | Sedecal Mobile Digital Diagnostic X-Ray | Sedecal., Sa. | 2011 | 4 |
| −4 | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | 2016 | 13 |
| −3 | K192011 | PhoeniX | Sedecal., Sa. | 2019 | — |
| −2 | K212291 | Phoenix | Sedecal., Sa. | 2021 | 1 |
| −1 | K222951 | SM-V | Sedecal., Sa. | 2022 | — |
| 0 (this device) | K231577 | MOBILETT Impact | Siemens Medical Solutions | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 23 ancestors have a recall of any class.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231577: MOBILETT Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231577
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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