510(k) · Cleared
ClearedMobile X-ray unit (!M1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solutions For Tomorrow AB · IZL System, X-Ray, Mobile
Cleared on Oct 24, 2025 as substantially equivalent to K241980 (Solutions For Tomorrow AB, 2025) after a 143-day review. Its family tree reaches back 12 generations to 1998.
- Decided
- Oct 24, 2025
- Review
- 143 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K981556 (1998). 55 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations between
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 1 generation backK241980 !M1Solutions For Tomorrow AB · 2025
- This deviceK251710 Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025
Show all 12 generations
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 10 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 9 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 8 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 7 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 6 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 5 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 4 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 1 generation backK241980 !M1Solutions For Tomorrow AB · 2025
- This deviceK251710 Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −11 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −10 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −9 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −8 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −7 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −6 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −5 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −4 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −3 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| −2 | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
| −1 | K241980 | !M1 | Solutions For Tomorrow AB | 2025 | — |
| 0 (this device) | K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K241980 | !M1Summary page 6…icate Device The following is the identified predicate device: Manufacturer: Solutions for tomorrow AB 510(k) Number: K241980 Device Trade Name: Mobile X-ray Unit (!M1) Device Common Name: Mobile x-ray system Cl… | 2025 |
| † | K223267 | SKR 3000 | 2022 |
| † | K230175 | Digital Radiography CXDI-CS01 | 2023 |
| † | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | 2022 |
| † | K200418 | Vivix-S VW | 2020 |
| † | K244010 | ExamVue Apex | 2025 |
| † | K213057 | ExamVue Duo | 2022 |
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 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 55 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. 2025, 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 device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.
Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251710: Mobile X-ray unit (!M1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251710
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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