510(k) · Cleared
ClearedSedecal
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 Jan 26, 2011 as substantially equivalent to K020436 (Sedecal., Sa., 2002) after a 56-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020436 (2002). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020436 Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0Sedecal., Sa. · 2002 · Recalled
- This deviceK103522 SedecalSedecal., Sa. · 2011
- Descendant · cites it directly · 5 of its ownK121410 Dragon LWSedecal., Sa. · 2012
- Descendant · 2 generations on · 4 of its ownK173299 Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018
- Descendant · 3 generations on · 3 of its ownK182317 AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
- Descendant · 4 generations on · 0 of its ownK250976 Airbile-100Poskom Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222258 Combined High Frequency X-ray SourceSuzhou Powersite Electric Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121410Dragon LWSedecal., Sa. · 2012 · cites it directly5descendants
- K173299Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018 · 2 generations on4descendants
- K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018 · 3 generations on3descendants
- K250976Airbile-100Poskom Co., Ltd. · 2025 · 4 generations on0descendants
- K222258Combined High Frequency X-ray SourceSuzhou Powersite Electric Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020436 | Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0 | Sedecal., Sa. | 2002 | 1 |
| 0 (this device) | K103522 | Sedecal | Sedecal., Sa. | 2011 | — |
| +1 | K121410 | Dragon LW | Sedecal., Sa. | 2012 | — |
| +2 | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | Sedecal., Sa. | 2018 | — |
| +3 | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018 | — |
| +4 | K250976 | Airbile-100 | Poskom Co., Ltd. | 2025 | — |
| +1 | K222258 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K020436 | Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0Summary page 1…L-HF-2.0) Classification Name: Mobile x-ray system, Product Code IZL Common/Usual Name: Mobile Diagnostic X-Ray System 3. Equivalent legally marketed device: K020436 Sedecal Models SP-HF-2.8 and SP-HF-4.0 4. Description of the Device: The Sedecal SPL-1-F-4.0 portable x-ray generator consists o… | 2002 |
What descends from it? (7)
2 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?
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
This Portable Diagnostic Radiographic System is 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/K103522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103522: Sedecal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103522
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