510(k) · Cleared
ClearedLumos 3DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Dio · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 6, 2023 as substantially equivalent to K211014 (Surround Medical Systems, 2021) after a 202-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 6, 2023
- Review
- 202 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935046 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 6 generations backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- 5 generations backK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- 4 generations backK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- 3 generations backK163519 RX DCCefla S.C. · 2017
- 2 generations backK182206 RiX70 DCTrident S.R.L · 2018
- 1 generation backK211014 PortraySurround Medical Systems · 2021
- This deviceK223780 Lumos 3DX3Dio · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −6 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| −5 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| −4 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| −3 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| −2 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| −1 | K211014 | Portray | Surround Medical Systems | 2021 | — |
| 0 (this device) | K223780 | Lumos 3DX | 3Dio | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K211014 | PortraySummary page 4…Manufacturer: Surround Medical Systems Trade Name: Portray System 510(k): K211014 Class: II Common/Usual Name: Extraoral source x-ray sys… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
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 Lumos 3DX ™ System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 3D imaging for diagnostic purposes via tomosynthesis. For use on adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223780: Lumos 3DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223780
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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