510(k) · Cleared
ClearedVolux 21C, Digital Extraoral Source X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jul 10, 2012 as substantially equivalent to K102124 (VATECH Co., Ltd., 2010) after a 162-day review. Its family tree reaches back 5 generations to 1997. 14 later devices descend from it.
- Decided
- Jul 10, 2012
- Review
- 162 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973642 (1997). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 4 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 3 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 2 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 1 generation backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- This deviceK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- Descendant · cites it directly · 13 of its ownK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- Descendant · 2 generations on · 6 of its ownK133620 Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014
- Descendant · 2 generations on · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 2 of its ownK162085 i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016
- Descendant · 3 generations on · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123070Galileos FamilySirona Dental Systems GmbH · 2013 · cites it directly13descendants
- K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014 · 2 generations on6descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · 2 generations on5descendants
- K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016 · 2 generations on2descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −4 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −3 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −2 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −1 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| 0 (this device) | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| +1 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| +2 | K133620 | Cone Beam 3D and 2D Panoramic Dental Imaging System | Imaging Sciences International | 2014 | — |
| +2 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | 2016 | — |
| +3 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K102124 | Dental Computed Tomography X-Ray SystemSummary page 1…us > Manufacturer: Vatech Co.. Ltd. Device Name: PaX-Reve3D Plus 510(k) Number: K 102124 (Decision Date: Oct. 22, 2010) 5. Description of the Device VOLUX 21C is a diagnostic imaging system which… | 2010 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123070 | Galileos Family | 2013 | 13 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123070 (Sirona Dental Systems GmbH, 2013) has gone furthest, with 13 descendants of its own.
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?
VOLUX 21IC is a Computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and cranjoifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360 rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120263: Volux 21C, Digital Extraoral Source 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/K120263
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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