510(k) · Cleared
ClearedADX6000 Portable X-Ray System; iRayA6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcowin Co., Ltd. · IZL System, X-Ray, Mobile
Cleared on Oct 5, 2015 as substantially equivalent to K040046 (Minxray, Inc., 2004) and 1 other predicate after a 300-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 5, 2015
- Review
- 300 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945707 (1995). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- 2 generations backK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- 1 generation backK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- This deviceK143494 ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK260236 XLITEGemss Healthcare CO., LTD. · 2026
- Descendant · cites it directly · 0 of its ownK253244 AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F…Poskom Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −2 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| −1 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| 0 (this device) | K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015 | — |
| +1 | K260236 | XLITE | Gemss Healthcare CO., LTD. | 2026 | — |
| +1 | K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K040046 | Minxray, Model HF120/60H PowerplusSummary page 6…ZL Submission Type: 510(k) Regulatory Class: 2 Predicate Devices The following predicates are legally marketed, post-amendment devices: 510(k) Number: K040046 Clearance Date: February 2, 2004 510(k) Trade Name: MinXray HF120/60H PowerPlus Submitters: Mikasa X-Ray Co.,… | 2004 |
| * | K052721 | Minxray, Model HF100H+Summary page 6…Mikasa X-Ray Co., Ltd. (Tokyo, Japan) MinXray, Inc. (Northbrook, Illinois, USA) Regulation & PC: 21 CFR 892.1720; IZL 510(k) Number: K052721 Clearance Date: October 27, 2005 510(k) Trade Name: MinXray HF100H+ Submitters: Mikasa X-Ray Co., Ltd. (Tokyo,… | 2005 |
What descends from it? (2)
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K260236 (Gemss Healthcare CO., LTD., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040046.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ADX6000 (also known as iRay A6) is a handheld and portable general purpose X-ray system. The device uses a variable tube
current with voltage from 50-80 kVp and, therefore, is limited to taking diagnostic x-rays of extremities.
It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. This device is not intended for
mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143494: ADX6000 Portable X-Ray System; iRayA6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143494
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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