510(k) · Cleared
ClearedDHX-70H, XTG-70H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digimed Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Mar 3, 2023 as substantially equivalent to K132041 (Meta Biomed, Inc., 2013) after a 275-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Mar 3, 2023
- Review
- 275 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000061 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 6 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 5 generations backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- 4 generations backK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- 3 generations backK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · Recalled
- 2 generations backK122016 Rextar, Rextar LCDMeta Biomed, Inc. · 2013
- 1 generation backK132041 Rextar XMeta Biomed, Inc. · 2013
- This deviceK221587 DHX-70H, XTG-70HDigimed Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −6 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −5 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| −4 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| −3 | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | 1 |
| −2 | K122016 | Rextar, Rextar LCD | Meta Biomed, Inc. | 2013 | — |
| −1 | K132041 | Rextar X | Meta Biomed, Inc. | 2013 | — |
| 0 (this device) | K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K132041 | Rextar XSummary page 4…Common Name Portable X-Ray System Regulation name Extra-oral source x-ray system (21CFR 872.1800) 510(k) Number: K132041 Device Class Class II Product Code EHD 4. Description of Device The portable x-ray syst… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 5 other devices also cite its predicate K132041.
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. 2023, 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 device is intended to be used by trained dentists and dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221587: DHX-70H, XTG-70H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221587
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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