510(k) · Cleared
ClearedMinxray HF100H High Frequency Diagnostic X-Ray Unit
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 Dec 12, 1997 as substantially equivalent to K945707 (Minxray, Inc., 1995) after a 74-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it.
- Decided
- Dec 12, 1997
- Review
- 74 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945707 (1995). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- This deviceK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- 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 · 2 of its ownK203658 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK193535 EZER, Portable X-ray SystemLivermoretech, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK143494 ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K052721Minxray, Model HF100H+Minxray, Inc. · 2005 · cites it directly16descendants
- K140723Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014 · 2 generations on8descendants
- K203658Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021 · 3 generations on2descendants
- K193535EZER, Portable X-ray SystemLivermoretech, Inc. · 2020 · 3 generations on2descendants
- K143494ADX6000 Portable X-Ray System; iRayA6Dexcowin Co., Ltd. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| 0 (this device) | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| +1 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| +2 | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| +3 | K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +3 | K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | 2020 | — |
| +2 | K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray UnitSummary page 1…cy Diagnostic X-ray Unit 2. Equivalent legally marketed device This product is similar in design and function to the MinXray HF80H High Frequency Diagnostic X-ray Unit (K945707). 3. Indications for Use (intended use) The MinXray HF100H will be initially marketed for portable and mobile general purpose d… | 1995 |
What descends from it? (18)
See all 182 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?
- Its one ancestor has no recall.
- Of its descendants, K052721 (Minxray, Inc., 2005) has gone furthest, with 16 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 HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.…
Read the full statement (153 words)
The MinXray HF100H will be initially marketed for portable and mobile general purpose
diagnostic medical radiography. Because of its compact size and high output to weight
ratio, we anticipate that the initial uses will be in field, home care, and nursing home
diagnostic radiographic applicatons. These uses are typical of the predicate device, the
MinXray HF80H. We believe that the safety and effectiveness of the two models are
substantially equivalent.
Experience in the market with the HF100H may make us aware of other possible
applications. This unit may be eventually married with stands for permanent or
semi-permanent installation for intra-operative use, hand and/or foot radiography, or other
medical diagnostic applications. MinXray will make some stands available for use the HF100H. Other manufacturers may make stands compatible with various
portable X-ray units, and we anticipate that some end users will purchase a MinXray
HF100H to be used with some other stand of their choice.
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/K973712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973712: Minxray HF100H High Frequency Diagnostic X-Ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973712
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