510(k) · Cleared
Recalled · Class II · 2025MobileDiagnost wDR 2.2
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 Aug 2, 2019 as substantially equivalent to K141895 (Sedecal., Sa., 2014) after a 28-day review. Its family tree reaches back 8 generations to 1998. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Aug 2, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981556 (1998). 16 ancestors in all, the oldest K931071 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 6 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 5 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 4 generations backK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
- 3 generations backK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
- 2 generations backK111725 Mobilediagnost WDRSedecal., Sa. · 2011 · Recalled
- 1 generation backK141895 Mobilediagnost WDRSedecal., Sa. · 2014 · Recalled
- This deviceK191813 MobileDiagnost wDR 2.2Sedecal., Sa. · 2019
- Descendant · cites it directly · 0 of its ownK233678 Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −7 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −6 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −5 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −4 | K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal., Sa. | 2004 | — |
| −3 | K090322 | Easy Moving Plus, SM-XXHF-YY | Sedecal., Sa. | 2009 | 31 |
| −2 | K111725 | Mobilediagnost WDR | Sedecal., Sa. | 2011 | 8 |
| −1 | K141895 | Mobilediagnost WDR | Sedecal., Sa. | 2014 | 2 |
| 0 (this device) | K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | 2019 | — |
| +1 | K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024 | 1 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141895 | Mobilediagnost WDRSummary page 4…MobileDiagnost wDR 2.0 Manufacturer: Sedecal SA 510(k) Clearance: K141895-September 18, 2014 Classification Regulation: 21CFR 892.1720 Cl… | 2014 |
| † | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | 2014 |
| † | K153318 | Philips Eleva Workspot with SkyFlow | 2015 |
| † | K182973 | DigitalDiagnost C90 | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233678 | Radiography 7000 M | 2024 | 0 |
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-0276-2026 | 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… |
| 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… |
| May 23, 2023 | Class II | Z-2045-2023 | Software change control | There is a software login in issue that may prevent the user from logging in. |
| 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.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K233678 (Philips Medical Systems Dmc GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141895.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191813: MobileDiagnost wDR 2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191813
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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