510(k) · Cleared
Recalled · 2026Radiography 7000 M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · IZL System, X-Ray, Mobile
Cleared on Feb 14, 2024 as substantially equivalent to K191813 (Sedecal., Sa., 2019) after a 90-day review. Its family tree reaches back 9 generations to 1998. It has been recalled once.
- Decided
- Feb 14, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 17 ancestors in all, the oldest K931071 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK111725 Mobilediagnost WDRSedecal., Sa. · 2011 · Recalled
- 2 generations backK141895 Mobilediagnost WDRSedecal., Sa. · 2014 · Recalled
- 1 generation backK191813 MobileDiagnost wDR 2.2Sedecal., Sa. · 2019 · Recalled
- This deviceK233678 Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
- 4 generations backK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
- 3 generations backK111725 Mobilediagnost WDRSedecal., Sa. · 2011 · Recalled
- 2 generations backK141895 Mobilediagnost WDRSedecal., Sa. · 2014 · Recalled
- 1 generation backK191813 MobileDiagnost wDR 2.2Sedecal., Sa. · 2019 · Recalled
- This deviceK233678 Radiography 7000 MPhilips Medical Systems Dmc GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal., Sa. | 2004 | — |
| −4 | K090322 | Easy Moving Plus, SM-XXHF-YY | Sedecal., Sa. | 2009 | 31 |
| −3 | K111725 | Mobilediagnost WDR | Sedecal., Sa. | 2011 | 8 |
| −2 | K141895 | Mobilediagnost WDR | Sedecal., Sa. | 2014 | 2 |
| −1 | K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | 2019 | 4 |
| 0 (this device) | K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K191813 | MobileDiagnost wDR 2.2Summary page 5…ic Technology The proposed Radiography 7000 M is substantially equivalent to the manufacturer’s legally marketed devices: • Predicate Device: MobileDiagnost wDR 2.2 (K191813 - August 2, 2019), Philips Medical Systems DMC A detailed comparison of the proposed and predicate device (K191813) is provided i… | 2019 |
| † | K232185 | SM-IV | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2026 | Not classified | Z-0288-2027 | Software design | Potential for the device to fail immediately after an exposure, causing the system to remain stationary. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 9 of the 17 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. 2024, 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 Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233678: Radiography 7000 M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233678
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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