510(k) · Cleared
ClearedPortable X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on May 16, 2013 as substantially equivalent to K063121 (Genoray Co., Ltd., 2007) after a 302-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- May 16, 2013
- Review
- 302 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000061 (2000). 2 later devices descend from it, 2 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 deviceK122124 Portable X-Ray SystemOsstem Implant Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK180671 MINERht Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK141497 Portable X-Ray System (Model:Exaro,XRAY2GO)Osstem Implant Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K122124 | Portable X-Ray System | Osstem Implant Co., Ltd. | 2013 | — |
| +1 | K180671 | MINE | Rht Co., Ltd. | 2019 | — |
| +1 | K141497 | Portable X-Ray System (Model:Exaro,XRAY2GO) | Osstem Implant Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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 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…Manufacturer: GENORAY Co.,Ltd. Device Name: Portable X-Ray Systemn(Model:PORT X 11) 510(k) Number: K063 121 (Decision Date - Jan. 11. 2007) Classification: Extraorai Source X-Ray System: EH-D, Class II per… | 2007 |
What descends from it? (2)
2 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 13 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K180671 (Rht Co., Ltd., 2019) has gone furthest, with 0 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. 2013, 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:EXARO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122124: Portable 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/K122124
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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