510(k) · Cleared
ClearedMobileDiagnost M50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips India Limited · IZL System, X-Ray, Mobile
Cleared on Nov 16, 2017 as substantially equivalent to K141895 (Sedecal., Sa., 2014) after a 45-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Nov 16, 2017
- Review
- 45 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981556 (1998). 16 ancestors in all, the oldest K931071 (1994). No later device cites it as a predicate yet.
- 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 deviceK173187 MobileDiagnost M50Philips India Limited · 2017
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) | 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 |
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 5…MobileDiagnost wDR 2.0 Predicate Device: Manufacturer: SEDECAL SA 510(k) Clearance: K141895 (September 18, 2014) Classification Regulation: 21 CFR, Part 892.1720 Cla… | 2014 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
| † | K153318 | Philips Eleva Workspot with SkyFlow | 2015 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 16 ancestors have a recall of any class.
- 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. 2017, 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 MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can’t be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173187: MobileDiagnost M50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173187
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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