510(k) · Cleared
ClearedNomad Dental X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aribex, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 14, 2005 as substantially equivalent to K021378 (Dentalez Group, 2002) after a 9-day review. Its family tree reaches back 2 generations to 2000. 47 later devices descend from it.
- Decided
- Jul 14, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000061 (2000). 47 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 1 generation backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- This deviceK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- Descendant · cites it directly · 24 of its ownK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- Descendant · 2 generations on · 18 of its ownK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · Recalled
- Descendant · cites it directly · 17 of its ownK081664 Nomad Pro X-Ray SystemAribex, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 9 of its ownK173319 KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017
- Descendant · 2 generations on · 8 of its ownK122016 Rextar, Rextar LCDMeta Biomed, Inc. · 2013
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K063121Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007 · cites it directly24descendants
- K082167Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · 2 generations on18descendants
- K081664Nomad Pro X-Ray SystemAribex, Inc. · 2008 · cites it directly17descendants
- K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017 · 2 generations on9descendants
- K122016Rextar, Rextar LCDMeta Biomed, Inc. · 2013 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −1 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| 0 (this device) | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| +1 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| +2 | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | 1 |
| +1 | K081664 | Nomad Pro X-Ray System | Aribex, Inc. | 2008 | 2 |
| +2 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | 2017 | — |
| +2 | K122016 | Rextar, Rextar LCD | Meta Biomed, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 6 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K021378 | Portable HDX Intraoral X-RaySummary page 1…ection 872.1800) Common/Usual Name: Portable Dental X-ray System 3. Predicate Device: Portable HDX Intraoral X-ray system, (K021378), manufactured by Flow X-Ray. Literature included at Tab 11. 4. Description: NOMADTM Dental i… | 2002 |
What descends from it? (47)
See all 475 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 5 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K063121 (Genoray Co., Ltd., 2007) has gone furthest, with 24 descendants of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The NOMAD DENTAL X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051795: Nomad Dental 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/K051795
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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