510(k) · Cleared
Recalled · Class II · 2025Portable X-Ray System, Models Diox-602, Prox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digimed Corporation · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 26, 2008 as substantially equivalent to K063121 (Genoray Co., Ltd., 2007) after a 57-day review. Its family tree reaches back 4 generations to 2000. 18 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000061 (2000). 18 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 3 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 2 generations backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- 1 generation backK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- This deviceK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008
- Descendant · cites it directly · 8 of its ownK122016 Rextar, Rextar LCDMeta Biomed, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK152859 Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015
- Descendant · 2 generations on · 7 of its ownK132041 Rextar XMeta Biomed, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK180561 MobileX Portable X-ray SystemDenterprise International, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK232068 HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K122016Rextar, Rextar LCDMeta Biomed, Inc. · 2013 · cites it directly8descendants
- K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015 · cites it directly7descendants
- K132041Rextar XMeta Biomed, Inc. · 2013 · 2 generations on7descendants
- K180561MobileX Portable X-ray SystemDenterprise International, Inc. · 2018 · 2 generations on5descendants
- K232068HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −3 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −2 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| −1 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| 0 (this device) | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | — |
| +1 | K122016 | Rextar, Rextar LCD | Meta Biomed, Inc. | 2013 | — |
| +1 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015 | — |
| +2 | K132041 | Rextar X | Meta Biomed, Inc. | 2013 | — |
| +2 | K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018 | — |
| +3 | K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K063121 | Portable X-Ray System, Model Port-X IISummary page 1…Extraoral Source x-Ray System: EHD, Class II per regulation 21CFR 872.1800 5 10(k) Number: K063121 (Decision Date: Jan. 11, 2007) 15 5.5 Indications for Use (… | 2007 |
What descends from it? (18)
See all 183 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 |
|---|---|---|---|---|
| Jun 19, 2025 | Class II | Z-2117-2025 | Radiation Control for Health and Safety Act | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K122016 (Meta Biomed, Inc., 2013) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K063121.
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 Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082167: Portable X-Ray System, Models Diox-602, Prox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082167
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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