510(k) · Cleared
ClearedNomad MD 75K V Handheld X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aribex, Inc. · IZL System, X-Ray, Mobile
Cleared on Aug 19, 2014 as substantially equivalent to K052721 (Minxray, Inc., 2005) after a 151-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Aug 19, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945707 (1995). 4 ancestors in all. 8 later devices descend from it, 3 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 deviceK140723 Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK203658 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK193535 EZER, Portable X-ray SystemLivermoretech, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK211473 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK203667 EzRay M (Model: VMX-P300)VATECH Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK244049 Europa (Alternative: AiRTouch) portable X-ray systemLivermoretech, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203658Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021 · cites it directly2descendants
- K193535EZER, Portable X-ray SystemLivermoretech, Inc. · 2020 · cites it directly2descendants
- K211473Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021 · 2 generations on1descendant
- K203667EzRay M (Model: VMX-P300)VATECH Co., Ltd. · 2021 · cites it directly1descendant
- K244049Europa (Alternative: AiRTouch) portable X-ray systemLivermoretech, Inc. · 2025 · 2 generations on0descendants
View 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) | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| +1 | K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +1 | K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | 2020 | — |
| +2 | K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +1 | K203667 | EzRay M (Model: VMX-P300) | VATECH Co., Ltd. | 2021 | — |
| +2 | K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K052721 | Minxray, Model HF100H+Summary page 5…21CFR 892.1720 • Product Code: IZL Predicate Device for Which Substantial Equivalence is Claimed: MinXray HF 100H+ Portable X-ray Unit (K052721) Device Description: The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a recharge… | 2005 |
What descends from it? (8)
3 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 19 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, K203658 (Oxos Medical, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K052721.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (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. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140723: Nomad MD 75K V Handheld X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140723
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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