510(k) · Cleared
ClearedRX DC X-Ray Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C.R.L. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Mar 14, 2008 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 14, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK080076 RX DC X-Ray UnitCefla S.C.R.L. · 2008
- Descendant · cites it directly · 4 of its ownK163519 RX DCCefla S.C. · 2017
- Descendant · 2 generations on · 3 of its ownK182206 RiX70 DCTrident S.R.L · 2018
- Descendant · 3 generations on · 1 of its ownK211014 PortraySurround Medical Systems · 2021
- Descendant · 3 generations on · 0 of its ownK232085 Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK223780 Lumos 3DX3Dio · 2023
Most influential descendants
Showing 5 of 5 · See all- K163519RX DCCefla S.C. · 2017 · cites it directly4descendants
- K182206RiX70 DCTrident S.R.L · 2018 · 2 generations on3descendants
- K211014PortraySurround Medical Systems · 2021 · 3 generations on1descendant
- K232085Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd. · 2023 · 3 generations on0descendants
- K223780Lumos 3DX3Dio · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080076 | RX DC X-Ray Unit | Cefla S.C.R.L. | 2008 | — |
| +1 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| +2 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| +3 | K211014 | Portray | Surround Medical Systems | 2021 | — |
| +3 | K232085 | Dvas (Dvas-M, Dvas-W) | Genoray Co., Ltd. | 2023 | — |
| +4 | K223780 | Lumos 3DX | 3Dio | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163519 | RX DC | 2017 | 4 |
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?
- Of its descendants, K163519 (Cefla S.C., 2017) has gone furthest, with 4 descendants of its own.
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. 2008, 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?
This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080076: RX DC 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/K080076
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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