510(k) · Cleared
ClearedPortable Dental X-ray Device (GT-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Refine Medical Instrument Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Feb 19, 2026 as substantially equivalent to K232068 (Changzhou Sifary Medical Technology Co., Ltd., 2023) after a 66-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Feb 19, 2026
- Review
- 66 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000061 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 7 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 6 generations backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- 5 generations backK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- 4 generations backK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · Recalled
- 3 generations backK152859 Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015
- 2 generations backK180561 MobileX Portable X-ray SystemDenterprise International, Inc. · 2018
- 1 generation backK232068 HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. · 2023
- This deviceK254018 Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −7 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −6 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| −5 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| −4 | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | 1 |
| −3 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015 | — |
| −2 | K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018 | — |
| −1 | K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K232068 | HyperLight Portable X-ray UnitSummary page 5…n: Extraoral source x-ray system Regulation Number: 21 CFR §872.1800 Product Code: EHD Classification: Class II III. 807.92(a)(3): PREDICATE DEVICE Predicate Device: K232068 Device Name: HyperLight Portable X-ray Unit Regulation Description: Extraoral source x-ray system Regulation Number: 21 CFR §872.… | 2023 |
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 26 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K232068.
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. 2026, 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 Dental X-ray Device is intended to be used by dental professionals to provide an extraoral X-ray source to produce radiographic images of the teeth using intraoral image receptors for clinical diagnostic purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254018 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254018: Portable Dental X-ray Device (GT-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254018
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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