510(k) · Cleared
ClearedGalileos Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 15, 2013 as substantially equivalent to K060892 (Sirona Dental Systems GmbH, 2006) and 1 other predicate after a 165-day review. Its family tree reaches back 6 generations to 1997. 13 later devices descend from it.
- Decided
- Mar 15, 2013
- Review
- 165 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K973642 (1997). 10 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 4 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 3 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 2 generations backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- 1 generation backK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- This deviceK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- Descendant · cites it directly · 6 of its ownK133620 Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014
- Descendant · cites it directly · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 2 of its ownK162085 i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016
- Descendant · 2 generations on · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK243337 Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014 · cites it directly6descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · cites it directly5descendants
- K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016 · cites it directly2descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · 2 generations on2descendants
- K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −5 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −4 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −3 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −2 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| −1 | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| 0 (this device) | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| +1 | K133620 | Cone Beam 3D and 2D Panoramic Dental Imaging System | Imaging Sciences International | 2014 | — |
| +1 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +1 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | 2016 | — |
| +2 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +2 | K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K060892 | GalileosSummary page 1…mon/Usual Name: X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system 3. Predicate Devices Sirona GALILEOS (K060892), Genoray VOLUX 21C (K120263) 4. Intended Use Devices of the GALILEOS family consist of an x-ray system that uses a cone beam w… | 2006 |
| * | K120263 | Volux 21C, Digital Extraoral Source X-Ray SystemSummary page 1…ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system 3. Predicate Devices Sirona GALILEOS (K060892), Genoray VOLUX 21C (K120263) 4. Intended Use Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, pr… | 2012 |
What descends from it? (13)
See all 133 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 16 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K133620 (Imaging Sciences International, 2014) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K060892.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.
Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123070: Galileos Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123070
Report an extraction error
Are you the manufacturer?
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