510(k) · Cleared
Recalled · Class II · 2016Nomad Pro 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 Jun 23, 2008 as substantially equivalent to K051795 (Aribex, Inc., 2005) after a 10-day review. Its family tree reaches back 3 generations to 2000. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 23, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000061 (2000). 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 2 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 1 generation backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- This deviceK081664 Nomad Pro X-Ray SystemAribex, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK173319 KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017
- Descendant · cites it directly · 5 of its ownK161063 EzRay Air (Model VEX-P300)VATECH Co., Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK200182 EzRay Air Portable (Model: VEX-P300)VATECH Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK222569 Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK221233 DT-703Ecotron Co., Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017 · cites it directly9descendants
- K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd. · 2016 · cites it directly5descendants
- K200182EzRay Air Portable (Model: VEX-P300)VATECH Co., Ltd. · 2020 · 2 generations on4descendants
- K222569Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 3 generations on1descendant
- K221233DT-703Ecotron Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −2 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −1 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| 0 (this device) | K081664 | Nomad Pro X-Ray System | Aribex, Inc. | 2008 | — |
| +1 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | 2017 | — |
| +1 | K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | 2016 | — |
| +2 | K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | 2020 | — |
| +3 | K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
| +2 | K221233 | DT-703 | Ecotron Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0063121 | Port-X 11 Portable X-ray System Number could not be read Summary page 1…section 872.1800) Common/Usual Name: Hand held Dental X-ray System Predicate Device: Port-X 11Portable X-ray System, 510(k) # K0063121, manufactured by Genoray, and the NOMAD Dental X-ray System, 51 0(k) #K051795, manufactured by Aribex. Literature inc… | |
| * | K051795 | Nomad Dental X-Ray SystemSummary page 1…X-ray System Predicate Device: Port-X 11Portable X-ray System, 510(k) # K0063121, manufactured by Genoray, and the NOMAD Dental X-ray System, 51 0(k) #K051795, manufactured by Aribex. Literature included at Tab 12. 3. Description: NOMAD Pro is a handheld dental X-ray system that oper… | 2005 |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2016 | Class II | Z-2717-2016 | Other | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a… |
| Jul 18, 2016 | Class II | Z-2716-2016 | Other | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K173319 (Aribex, 2017) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K051795.
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. 2008, this device’s year, is highlighted.
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 Pro 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/K081664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081664: Nomad Pro X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081664
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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