510(k) · Cleared
ClearedPortable X-Ray System
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 Apr 8, 2011 as substantially equivalent to K063121 (Genoray Co., Ltd., 2007) after a 121-day review. Its family tree reaches back 4 generations to 2000. 8 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000061 (2000). 8 later devices descend from it, 1 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 deviceK103600 Portable X-Ray SystemDigimed Corporation · 2011
- 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 · 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
- Descendant · 3 generations on · 1 of its ownK231449 Portable X-ray System Model Ray98(P)Ningbo Runyes Medical Instrument Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK260795 Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) · 2015 · cites it directly7descendants
- 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
- K231449Portable X-ray System Model Ray98(P)Ningbo Runyes Medical Instrument Co., Ltd. · 2023 · 3 generations on1descendant
- K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd. · 2026 · 4 generations on0descendants
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) | K103600 | Portable X-Ray System | Digimed Corporation | 2011 | — |
| +1 | 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 | — |
| +3 | K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023 | — |
| +3 | K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | 2023 | — |
| +4 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 2 | 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…assification: Extraoral Source X-Ray System: EHD, Class 11 per regulation 2ICFR 872.1800 5 10(k) Number: K063121 (Decision Date: Jan. 11, 2007) 5.5 Indications for Use (Intended Use):… | 2007 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | 2015 | 7 |
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 11 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, K152859 (Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012), 2015) has gone furthest, with 7 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. 2011, 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: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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/K103600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103600: 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/K103600
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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