510(k) · Cleared
ClearedPreXion3D Explorer PRO
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 Feb 23, 2021 as substantially equivalent to K193329 (Prexion Corporation, 2020) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 2019. 6 later devices descend from it.
- Decided
- Feb 23, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K190320 (2019). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK190320 PreXion3D ExplorerPrexion Corporation · 2019
- 1 generation backK193329 PreXion3D Explorer EXPrexion Corporation · 2020
- This deviceK203784 PreXion3D Explorer PROPrexion Corporation · 2021
- Descendant · cites it directly · 3 of its ownK221525 PreXion3D Explorer PROPrexion Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK232710 Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK222150 PreXion3D ExpeditionPrexion Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK251642 Dental CBCT X-ray SystemYian Medical Technology (Haining) Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK240855 Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221525PreXion3D Explorer PROPrexion Corporation · 2022 · cites it directly3descendants
- K232710Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024 · 2 generations on2descendants
- K222150PreXion3D ExpeditionPrexion Corporation · 2023 · cites it directly1descendant
- K251642Dental CBCT X-ray SystemYian Medical Technology (Haining) Co., Ltd. · 2025 · 3 generations on0descendants
- K240855Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K190320 | PreXion3D Explorer | Prexion Corporation | 2019 | — |
| −1 | K193329 | PreXion3D Explorer EX | Prexion Corporation | 2020 | — |
| 0 (this device) | K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021 | — |
| +1 | K221525 | PreXion3D Explorer PRO | Prexion Corporation | 2022 | — |
| +2 | K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024 | — |
| +1 | K222150 | PreXion3D Expedition | Prexion Corporation | 2023 | — |
| +3 | K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025 | — |
| +3 | K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K193329 | PreXion3D Explorer EXSummary page 5…= Page 5 === PreXion Corporation Traditional 510(k) Premarket Submission PreXion3D Explorer PRO 5. Legally Marketed Predicate Device(s) Predicate Device (Primary) : K193329, PreXion3D Explorer EX, PreXion Corporation Predicate Device (Seconday) : K190320, PreXion3D Explorer, PreXion Corporation… | 2020 |
| * | K190320 | PreXion3D ExplorerSummary page 5…plorer PRO 5. Legally Marketed Predicate Device(s) Predicate Device (Primary) : K193329, PreXion3D Explorer EX, PreXion Corporation Predicate Device (Seconday) : K190320, PreXion3D Explorer, PreXion Corporation 6. Indication for Use Statement PreXion3D Explorer PRO is intended to produce two… | 2019 |
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 2 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221525 (Prexion Corporation, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K193329.
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. 2021, 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 PRO 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.
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/K203784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203784: PreXion3D Explorer PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203784
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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