510(k) · Cleared
ClearedVivi Ergon-X HF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivi S.R.L. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 6, 2012 as substantially equivalent to K083344 (Sirona Dental Systems GmbH, 2008) and 2 other predicates after a 33-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Mar 6, 2012
- Review
- 33 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K935046 (1994). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 2 generations backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- 1 generation backK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- This deviceK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- 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 · cites it directly · 1 of its ownK130109 Endograph DCVilla Sistemi Medicali S.P.A. · 2013
- Descendant · 2 generations on · 0 of its ownK231055 x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark…De Götzen S.R.L. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K130109Endograph DCVilla Sistemi Medicali S.P.A. · 2013 · cites it directly1descendant
- K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −2 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| −1 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| 0 (this device) | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| +1 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| +2 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| +3 | K211014 | Portray | Surround Medical Systems | 2021 | — |
| +1 | K130109 | Endograph DC | Villa Sistemi Medicali S.P.A. | 2013 | — |
| +2 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark… | De Götzen S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K083344 | Heliodent PlusSummary page 1…ices: Appicant -' -. U.evice..namnet ,, L* Sirona Dental Systems GmbH IHELIOIDENT Plus IK083344 Villa Sistemi IENDOS DC K030634 Progeny Inc… | 2008 |
| * | K030634 | Endos DCSummary page 1…Sirona Dental Systems GmbH IHELIOIDENT Plus IK083344 Villa Sistemi IENDOS DC K030634 Progeny Inc PREVA I K043092… | 2003 |
| * | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Summary page 1…Villa Sistemi IENDOS DC K030634 Progeny Inc PREVA I K043092 Page 21… | 2004 |
What descends from it? (7)
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 18 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K163519 (Cefla S.C., 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K083344.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120318: Vivi Ergon-X HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120318
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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