510(k) · Cleared
ClearedVolux, 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 Apr 26, 2010 as substantially equivalent to K033248 (Hitachi Medical Systems America, Inc., 2003) and 1 other predicate after a 279-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Apr 26, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003787 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK003787 Newtom QR-DVT 9000Aperio Services, LLC · 2001
- 2 generations backK033248 Hitachi CB Mercuray Dental Cone-Beam X-Ray SystemHitachi Medical Systems America, Inc. · 2003
- 1 generation backK060892 GalileosSirona Dental Systems GmbH · 2006
- This deviceK092171 Volux, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003787 | Newtom QR-DVT 9000 | Aperio Services, LLC | 2001 | — |
| −2 | K033248 | Hitachi CB Mercuray Dental Cone-Beam X-Ray System | Hitachi Medical Systems America, Inc. | 2003 | — |
| −1 | K060892 | Galileos | Sirona Dental Systems GmbH | 2006 | — |
| 0 (this device) | K092171 | Volux, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2010 | — |
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? (2)
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 |
|---|---|---|---|
| * | K033248 | Hitachi CB Mercuray Dental Cone-Beam X-Ray SystemSummary page 1…Hitachi Medical Systems America, Inc, Device Name: CB MercuRay 5 10(k) Ntumber: K033248 (Decision Date - October 20, 2003) Classification: System, X-Ray, Extraoral Source, Digital… | 2003 |
| * | K060892 | GalileosSummary page 2…facturer: Sirona Decntal Systems GmbH1 Device Name: Gialileos 5 10(k) Number: K060892 (Decision I)ate - April 14. 2006) Classification: System. X-Ray. E~xiraoral Source, Digital : M… | 2006 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K033248.
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. 2010, 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?
The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support.
VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092171 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092171: Volux, Digital Extraoral Source X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092171
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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