510(k) · Cleared
Recalled · 2003Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0
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 Feb 22, 2002 after a 14-day review. The FDA summary names its predicate without a number. 25 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 1
- Predicates
- 0
25 later devices descend from it, 2 citing it directly.
- This deviceK020436 Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0Sedecal., Sa. · 2002
- Descendant · cites it directly · 22 of its ownK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
- Descendant · 2 generations on · 15 of its ownK082627 Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- Descendant · 4 generations on · 13 of its ownK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- Descendant · 5 generations on · 12 of its ownK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K042361Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004 · cites it directly22descendants
- K082627Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc. · 2008 · 2 generations on15descendants
- K100449Minxray Model CMDR-2SMinxray, Inc. · 2010 · 3 generations on14descendants
- K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014 · 4 generations on13descendants
- K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020436 | Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0 | Sedecal., Sa. | 2002 | — |
| +1 | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | Sedecal USA, Inc. | 2004 | — |
| +2 | K082627 | Minxray, Model CMDR-1S and CMDR-1S-Mil | Minxray, Inc. | 2008 | — |
| +3 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| +4 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
| +5 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | MinXray HF100H Named without a submission number |
What descends from it? (25)
See all 252 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 27, 2003 | Not classified | Z-0001-04 | Other | A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042361 (Sedecal USA, Inc., 2004) has gone furthest, with 22 descendants of its own.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020436: Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020436
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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