510(k) · Cleared
ClearedJADE Mobile X-Ray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRGEM Corporation · IZL System, X-Ray, Mobile
Cleared on Feb 5, 2019 as substantially equivalent to K182317 (Oehm Und Rehbein GmbH, 2018) after a 61-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Feb 5, 2019
- Review
- 61 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981556 (1998). 11 ancestors in all. 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 backK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
- 3 generations backK121410 Dragon LWSedecal., Sa. · 2012
- 2 generations backK173299 Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018
- 1 generation backK182317 AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
- This deviceK183388 JADE Mobile X-RayDRGEM Corporation · 2019
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 | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | Sedecal USA, Inc. | 2004 | — |
| −3 | K121410 | Dragon LW | Sedecal., Sa. | 2012 | — |
| −2 | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | Sedecal., Sa. | 2018 | — |
| −1 | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182317 | AMADEO M-DR mini, AMADEO M-AX miniSummary page 4…Product Code: IZL Device Classification: Class II Predicate Device: 21 CFR 807. 92(a)(3) The JADE Mobile X-Ray, device is substantially equivalent to K182317: Device Classification Name System, X-Ray, Mobile 510(K) Number K182317 Devi… | 2018 |
| † | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | 2016 |
| † | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | 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 21 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K182317.
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?
The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient’s anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183388: JADE Mobile X-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183388
Report an extraction error
Are you the manufacturer?
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