510(k) · Cleared
Recalled · Class II · 2025Mobilediagnost WDR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · IZL System, X-Ray, Mobile
Cleared on Jul 19, 2011 as substantially equivalent to K090322 (Sedecal., Sa., 2009) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1998. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 19, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981556 (1998). 14 ancestors in all, the oldest K931071 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
- 1 generation backK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
- This deviceK111725 Mobilediagnost WDRSedecal., Sa. · 2011
- Descendant · cites it directly · 3 of its ownK141895 Mobilediagnost WDRSedecal., Sa. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK191813 MobileDiagnost wDR 2.2Sedecal., Sa. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK233678 Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK173187 MobileDiagnost M50Philips India Limited · 2017
Most influential descendants
Showing 4 of 4 · See all- K141895Mobilediagnost WDRSedecal., Sa. · 2014 · cites it directly3descendants
- K191813MobileDiagnost wDR 2.2Sedecal., Sa. · 2019 · 2 generations on1descendant
- K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024 · 3 generations on0descendants
- K173187MobileDiagnost M50Philips India Limited · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal., Sa. | 2004 | — |
| −1 | K090322 | Easy Moving Plus, SM-XXHF-YY | Sedecal., Sa. | 2009 | 31 |
| 0 (this device) | K111725 | Mobilediagnost WDR | Sedecal., Sa. | 2011 | — |
| +1 | K141895 | Mobilediagnost WDR | Sedecal., Sa. | 2014 | 2 |
| +2 | K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | 2019 | 4 |
| +3 | K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024 | 1 |
| +2 | K173187 | MobileDiagnost M50 | Philips India Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K090322 | Easy Moving Plus, SM-XXHF-YYSummary page 1…r), MQB Common/Usual Name: Mobile Diagnostic X-ray System with Digital Panel 2. Equivalent legally marketed devices:. * Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) marketed by Sedecal * The Detector is identical to the Wireless Portable Detector FD-W 17 (K090625) marketed by Philips… | 2009 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 1…marketed devices:. * Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) marketed by Sedecal * The Detector is identical to the Wireless Portable Detector FD-W 17 (K090625) marketed by Philips Medical Systems 3. Description of the Device: This device is simply the combination of two cleared dev… | 2009 |
| † | K031447 | Canon, Digital Radiography, Model Cxdi-50G | 2003 |
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 |
|---|---|---|---|
| K141895 | Mobilediagnost WDR | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2025 | Class II | Z-0243-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Oct 14, 2021 | Class II | Z-1083-2024 | Use error | While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button.… |
| Jan 18, 2016 | Class II | Z-1084-2016 | Device Design | This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that… |
| Mar 23, 2015 | Class II | Z-1691-2016 | Radiation Control for Health and Safety Act | Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area… |
| Aug 6, 2014 | Class II | Z-1040-2015 | Other | Reports of unexpected movement. |
| Apr 8, 2014 | Class II | Z-0508-2015 | Software design | In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. |
| Jun 11, 2013 | Class II | Z-1964-2013 | Radiation Control for Health and Safety Act | The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3). |
| Nov 28, 2012 | Class II | Z-1706-2017 | Software design | When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K141895 (Sedecal., Sa., 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K090322.
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?
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111725: Mobilediagnost WDR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111725
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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