510(k) · Cleared
ClearedXLITE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemss Healthcare CO., LTD. · IZL System, X-Ray, Mobile
Cleared on Aug 3, 2026 as substantially equivalent to K143494 (Dexcowin Co., Ltd., 2015) after a 189-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 3, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945707 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- 3 generations backK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- 2 generations backK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- 1 generation backK143494 ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015
- This deviceK260236 XLITEGemss Healthcare CO., LTD. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −3 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| −2 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| −1 | K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015 | — |
| 0 (this device) | K260236 | XLITE | Gemss Healthcare CO., LTD. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K143494 | ADX6000 Portable X-Ray System; iRayA6Summary page 5…er: 21CFR 892.1720 - Regulation Name: Mobile X-Ray System - Device Class: Class II - Product Code: IZL 3 Predicate Device - K Number: K143494 - Manufacturer: DEXCOWIN - Trade Name: ADX6000 4 General Description The XLITE is a battery-powered portabl… | 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 31 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K143494.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260236: XLITE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260236
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026