510(k) · Cleared
ClearedAMADEO M-DR mini, AMADEO M-AX mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oehm Und Rehbein GmbH · IZL System, X-Ray, Mobile
Cleared on Sep 24, 2018 as substantially equivalent to K173299 (Sedecal., Sa., 2018) after a 28-day review. Its family tree reaches back 7 generations to 1998. 3 later devices descend from it.
- Decided
- Sep 24, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K981556 (1998). 10 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
- 2 generations backK121410 Dragon LWSedecal., Sa. · 2012
- 1 generation backK173299 Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018
- This deviceK182317 AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
- Descendant · cites it directly · 0 of its ownK250976 Airbile-100Poskom Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK212940 Skanmobile, Skanmobile-DrSkanray Technologies Limited · 2022
- Descendant · cites it directly · 0 of its ownK183388 JADE Mobile X-RayDRGEM Corporation · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | Sedecal USA, Inc. | 2004 | — |
| −2 | K121410 | Dragon LW | Sedecal., Sa. | 2012 | — |
| −1 | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | Sedecal., Sa. | 2018 | — |
| 0 (this device) | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018 | — |
| +1 | K250976 | Airbile-100 | Poskom Co., Ltd. | 2025 | — |
| +1 | K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022 | — |
| +1 | K183388 | JADE Mobile X-Ray | DRGEM Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HCSummary page 4…me: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Mobile Diagnostic X-Ray System 2. Equivalent legally marketed device: K173299 Trade/Device Name: DRAGON X SPSL4HC; DRAGON X SPSL8HC Manufacturer: Sedecal SA Regulation Number: 21CFR892.1720 Regul… | 2018 |
| † | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | 2016 |
| † | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | 2015 |
| † | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K250976 (Poskom Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173299.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182317: AMADEO M-DR mini, AMADEO M-AX mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182317
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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