510(k) · Cleared
ClearedRiX70 DC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trident S.R.L · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 13, 2018 as substantially equivalent to K163519 (Cefla S.C., 2017) after a 29-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it.
- Decided
- Sep 13, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935046 (1994). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 4 generations backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- 3 generations backK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- 2 generations backK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- 1 generation backK163519 RX DCCefla S.C. · 2017
- This deviceK182206 RiX70 DCTrident S.R.L · 2018
- Descendant · cites it directly · 1 of its ownK211014 PortraySurround Medical Systems · 2021
- Descendant · cites it directly · 0 of its ownK232085 Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223780 Lumos 3DX3Dio · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −4 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| −3 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| −2 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| −1 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| 0 (this device) | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| +1 | K211014 | Portray | Surround Medical Systems | 2021 | — |
| +1 | K232085 | Dvas (Dvas-M, Dvas-W) | Genoray Co., Ltd. | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K163519 | RX DCSummary page 4…II 510k Review Panel: Dental Predicate Device The subject device claims equivalence to the following legally marketed predicate: 510(k) Number: K163519 Date Cleared January 13, 2017 Trade Name: RX DC Common Name: Unit, X-Ray, Extraoral with… | 2017 |
What descends from it? (3)
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 24 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K211014 (Surround Medical Systems, 2021) has gone furthest, with 1 descendant 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. 2018, 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?
RiX70 DC X-ray Unit is designed for use in 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 summary.
https://510kreport.com/device/K182206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182206: RiX70 DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182206
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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