510(k) · Cleared
ClearedMinxray, Model HF100H+
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 Oct 27, 2005 as substantially equivalent to K973712 (Minxray, Inc., 1997) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1995. 16 later devices descend from it.
- Decided
- Oct 27, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945707 (1995). 3 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- 1 generation backK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- This deviceK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK140723 Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK203658 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK193535 EZER, Portable X-ray SystemLivermoretech, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK143494 ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK211473 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K140723Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014 · cites it directly8descendants
- K203658Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021 · 2 generations on2descendants
- K193535EZER, Portable X-ray SystemLivermoretech, Inc. · 2020 · 2 generations on2descendants
- K143494ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015 · cites it directly2descendants
- K211473Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −1 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| 0 (this device) | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| +1 | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| +2 | K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +2 | K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | 2020 | — |
| +1 | K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015 | — |
| +3 | K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray UnitSummary page 1…. 2. Equivalent legally marketed devices This product is similar in function to the MinXray T HFOGH K973712 and MinXray HF120/60H PowerPlus M K040046 3. Indications for Use (intended use) The MinXray HFIOOH+TM is intended fo… | 1997 |
| * | K040046 | Minxray, Model HF120/60H PowerplusSummary page 1…roduct is similar in function to the MinXray T HFOGH K973712 and MinXray HF120/60H PowerPlus M K040046 3. Indications for Use (intended use) The MinXray HFIOOH+TM is intended for use by a qualified/trained physician or tec… | 2004 |
What descends from it? (16)
See all 165 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 10 years and passes through 1 company; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140723 (Aribex, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K973712.
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 HF100H+TM 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/K052721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052721: Minxray, Model HF100H+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052721
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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