510(k) · Cleared
ClearedCone Beam 3D and 2D Panoramic Dental Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences International · OAS X-Ray, Tomography, Computed, Dental
Cleared on May 14, 2014 as substantially equivalent to K061284 (Imaging Sciences Intl., Inc., 2006) and 1 other predicate after a 170-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it.
- Decided
- May 14, 2014
- Review
- 170 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K973642 (1997). 15 ancestors in all, the oldest K973598 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 6 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 5 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 4 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 3 generations backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- 2 generations backK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- 1 generation backK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- This deviceK133620 Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014
- Descendant · cites it directly · 2 of its ownK162085 i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 1 of its ownK173878 PreXion3D ExcelsiorPrexion Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK260662 Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International · 2016 · cites it directly2descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · cites it directly2descendants
- K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K173878PreXion3D ExcelsiorPrexion Corporation · 2018 · 2 generations on1descendant
- K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −6 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −5 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −4 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −3 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| −2 | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| −1 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| 0 (this device) | K133620 | Cone Beam 3D and 2D Panoramic Dental Imaging System | Imaging Sciences International | 2014 | — |
| +1 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | 2016 | — |
| +1 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +2 | K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025 | — |
| +2 | K173878 | PreXion3D Excelsior | Prexion Corporation | 2018 | — |
| +3 | K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K061284 | I-Cat ScannerSummary page 1…ation name - Computed tomography x-ray system (21 CFR §892.1750, Product Code GAS) Devices for Which Substantial Equivalence is Claimed: * i-CAT Scanner, K06 1284 * GAL]ILEOS Comnfort Plus. K 123070 Device Description: i-CAT FLX was developed as an upgrade to the existing i-CAT Scann… | 2006 |
| * | K123070 | Galileos FamilySummary page 1…tem (21 CFR §892.1750, Product Code GAS) Devices for Which Substantial Equivalence is Claimed: * i-CAT Scanner, K06 1284 * GAL]ILEOS Comnfort Plus. K 123070 Device Description: i-CAT FLX was developed as an upgrade to the existing i-CAT Scanner. i-CAT FLX, manufactured by Imaging Sci… | 2013 |
What descends from it? (6)
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 17 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K162085 (Imaging Sciences International, 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K061284.
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. 2014, 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 i-CAT 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 maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses), for use in planning and diagnostic support in adult and pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133620
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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