510(k) · Cleared
ClearedPreXion3D Excelsior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prexion Corporation · OAS X-Ray, Tomography, Computed, Dental
Cleared on Oct 3, 2016 as substantially equivalent to K122199 (The Yoshida Dental Mfg. Co., Ltd., 2013) and 2 other predicates after an 87-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 3, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K973598 (1997). 30 ancestors in all, the oldest K930338 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 6 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 5 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 4 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 3 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 2 generations backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- 1 generation backK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- This deviceK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
- Descendant · cites it directly · 1 of its ownK173878 PreXion3D ExcelsiorPrexion Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK181983 PreXion 3D ExcelsiorPrexion Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −7 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −6 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −5 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −4 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −3 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −2 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| −1 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| 0 (this device) | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +1 | K173878 | PreXion3D Excelsior | Prexion Corporation | 2018 | — |
| +2 | K181983 | PreXion 3D Excelsior | Prexion Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K122199 | PREXION3D EclipseSummary page 4…Prexion3D Excelsior 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122199 K103659 K133620 Applicant: THE YOSHIDA Trophy I… | 2013 |
| * | K103659 | CS 9300, CS 9300CSummary page 4…xcelsior 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122199 K103659 K133620 Applicant: THE YOSHIDA Trophy Imaging Sciences… | 2011 |
| * | K133620 | Cone Beam 3D and 2D Panoramic Dental Imaging SystemSummary page 4…evices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122199 K103659 K133620 Applicant: THE YOSHIDA Trophy Imaging Sciences DENTAL MF… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173878 | PreXion3D Excelsior | 2018 | 1 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K173878 (Prexion Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122199.
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. 2016, 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?
PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial. and ENT (Ear. Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161881: PreXion3D Excelsior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161881
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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