510(k) · Cleared
ClearedPreXion3D Explorer EX
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 Apr 9, 2020 as substantially equivalent to K190320 (Prexion Corporation, 2019) after a 129-day review. Its family tree reaches back 1 generation to 2019. 8 later devices descend from it.
- Decided
- Apr 9, 2020
- Review
- 129 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190320 (2019). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK190320 PreXion3D ExplorerPrexion Corporation · 2019
- This deviceK193329 PreXion3D Explorer EXPrexion Corporation · 2020
- Descendant · cites it directly · 6 of its ownK203784 PreXion3D Explorer PROPrexion Corporation · 2021
- Descendant · 2 generations on · 3 of its ownK221525 PreXion3D Explorer PROPrexion Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK232710 Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK222150 PreXion3D ExpeditionPrexion Corporation · 2023
- Descendant · cites it directly · 0 of its ownK253935 medXion NEXUSmedXion Technologies, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203784PreXion3D Explorer PROPrexion Corporation · 2021 · cites it directly6descendants
- K221525PreXion3D Explorer PROPrexion Corporation · 2022 · 2 generations on3descendants
- K232710Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024 · 3 generations on2descendants
- K222150PreXion3D ExpeditionPrexion Corporation · 2023 · 2 generations on1descendant
- K253935medXion NEXUSmedXion Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190320 | PreXion3D Explorer | Prexion Corporation | 2019 | — |
| 0 (this device) | K193329 | PreXion3D Explorer EX | Prexion Corporation | 2020 | — |
| +1 | K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021 | — |
| +2 | K221525 | PreXion3D Explorer PRO | Prexion Corporation | 2022 | — |
| +3 | K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024 | — |
| +2 | K222150 | PreXion3D Expedition | Prexion Corporation | 2023 | — |
| +1 | K253935 | medXion NEXUS | medXion Technologies, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K190320 | PreXion3D ExplorerSummary page 5…Explorer EX 5. Legally Marketed Predicate Device(s) and Reference Device Predicate Device: Product/Trade Name: PreXion3D Explorer 510(K) Number: K190320 Common Name: Computed Tomography X-ray System Classification Name: Computed Tomography X-ray System Classi… | 2019 |
| † | K181983 | PreXion 3D Excelsior | 2018 |
What descends from it? (8)
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?
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. 2020, 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 Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in…
Read the full statement (145 words)
PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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.
This device is not intended for use on patients less than approximately 21 kg (46 lb) 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. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatric patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193329: PreXion3D Explorer EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193329
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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