510(k) · Cleared
ClearedDragon LW
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, 2012 as substantially equivalent to K103522 (Sedecal., Sa., 2011) and 1 other predicate after an 83-day review. Its family tree reaches back 5 generations to 1998. 5 later devices descend from it.
- Decided
- Aug 2, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981556 (1998). 8 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
- This deviceK121410 Dragon LWSedecal., Sa. · 2012
- Descendant · cites it directly · 4 of its ownK173299 Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018
- Descendant · 2 generations on · 3 of its ownK182317 AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
- Descendant · 3 generations on · 0 of its ownK250976 Airbile-100Poskom Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK212940 Skanmobile, Skanmobile-DrSkanray Technologies Limited · 2022
- Descendant · 3 generations on · 0 of its ownK183388 JADE Mobile X-RayDRGEM Corporation · 2019
Most influential descendants
Showing 5 of 5 · See all- K173299Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018 · cites it directly4descendants
- K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018 · 2 generations on3descendants
- K250976Airbile-100Poskom Co., Ltd. · 2025 · 3 generations on0descendants
- K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited · 2022 · 2 generations on0descendants
- K183388JADE Mobile X-RayDRGEM Corporation · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | Sedecal USA, Inc. | 2004 | — |
| 0 (this device) | K121410 | Dragon LW | Sedecal., Sa. | 2012 | — |
| +1 | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | Sedecal., Sa. | 2018 | — |
| +2 | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018 | — |
| +3 | K250976 | Airbile-100 | Poskom Co., Ltd. | 2025 | — |
| +2 | K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 2 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K103522 | SedecalSummary page 1…ital X-Ray Receptor Panel Product Code MQB CommonlUsual Name: Portable Diagnostic X-Ray System with Digital X-Ray Receptor 3. Equivalent legally marketed device: K103522 SPL-HF-4.0 Portable (Sedecal) AND K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (Sedecal) 4. Description of the Dev… | 2011 |
| * | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 DSummary page 1…CommonlUsual Name: Portable Diagnostic X-Ray System with Digital X-Ray Receptor 3. Equivalent legally marketed device: K103522 SPL-HF-4.0 Portable (Sedecal) AND K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (Sedecal) 4. Description of the Device: The Sedecal Dragon LW portable x-ray gen… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | 2018 | 4 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K173299 (Sedecal., Sa., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K103522.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/K121410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121410: Dragon LW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121410
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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