510(k) · Cleared
ClearedHyperLight Portable X-ray Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Sifary Medical Technology Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 1, 2023 as substantially equivalent to K180561 (Denterprise International, Inc., 2018) after a 51-day review. Its family tree reaches back 7 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 1, 2023
- Review
- 51 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000061 (2000). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK152859 Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015
- 1 generation backK180561 MobileX Portable X-ray SystemDenterprise International, Inc. · 2018
- This deviceK232068 HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK260795 Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK254018 Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −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 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015 | — |
| −1 | K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018 | — |
| 0 (this device) | K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023 | — |
| +1 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K180561 | MobileX Portable X-ray SystemSummary page 5…5.1-1 Predicate Device The subject device claims equivalence to the following legally marketed predicate: 510(k) Number: K180561 Applicant: MobileX Portable X-ray System (Model T-100). Date Cleared: April 4, 2018… | 2018 |
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 23 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K260795 (Changzhou Sifary Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180561.
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 HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232068: HyperLight Portable X-ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232068
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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