510(k) · Cleared
ClearedMinxray, Model HF120/60H Powerplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minxray, Inc. · IZL System, X-Ray, Mobile
Cleared on Feb 2, 2004 after a 21-day review. The FDA summary names its predicate without a number. 37 later devices descend from it.
- Decided
- Feb 2, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 5 citing it directly.
- This deviceK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- Descendant · cites it directly · 17 of its ownK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- Descendant · 2 generations on · 16 of its ownK182207 TR90BHMinxray, Inc. · 2018
- Descendant · cites it directly · 16 of its ownK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK140723 Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK212144 Remex KA6Remedi Co., Ltd. · 2021
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016 · cites it directly17descendants
- K182207TR90BHMinxray, Inc. · 2018 · 2 generations on16descendants
- K052721Minxray, Model HF100H+Minxray, Inc. · 2005 · cites it directly16descendants
- K140723Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014 · 2 generations on8descendants
- K212144Remex KA6Remedi Co., Ltd. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| +1 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| +2 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| +1 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| +2 | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| +3 | K212144 | Remex KA6 | Remedi Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 8 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 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? (37)
See all 375 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?
- Of its descendants, K153059 (Minxray, Inc., 2016) has gone furthest, with 17 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?
The MinXray HF120/60H PowerPlusTM is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040046: Minxray, Model HF120/60H Powerplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040046
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