510(k) · Cleared
ClearedPreXion3D Expedition
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 Sep 8, 2023 as substantially equivalent to K222150 (Prexion Corporation, 2023) after a 49-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Sep 8, 2023
- Review
- 49 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K190320 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK190320 PreXion3D ExplorerPrexion Corporation · 2019
- 3 generations backK193329 PreXion3D Explorer EXPrexion Corporation · 2020
- 2 generations backK203784 PreXion3D Explorer PROPrexion Corporation · 2021
- 1 generation backK222150 PreXion3D ExpeditionPrexion Corporation · 2023
- This deviceK232166 PreXion3D ExpeditionPrexion Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K190320 | PreXion3D Explorer | Prexion Corporation | 2019 | — |
| −3 | K193329 | PreXion3D Explorer EX | Prexion Corporation | 2020 | — |
| −2 | K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021 | — |
| −1 | K222150 | PreXion3D Expedition | Prexion Corporation | 2023 | — |
| 0 (this device) | K232166 | PreXion3D Expedition | Prexion Corporation | 2023 | — |
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? (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 |
|---|---|---|---|
| * | K222150 | PreXion3D ExpeditionSummary page 4…CFR 892.1750 Product Code OAS I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222150 PreXion3D Expedition OAS Device Description Summary 21 CFR 807.92(a)(4) PreXion3D Expedition consists of a scanner, which is use… | 2023 |
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 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
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. 2023, 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 Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck 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.
This device is not intended for use on patients less than approximately 21 kg (46 Ib) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
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/K232166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232166: PreXion3D Expedition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232166
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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