510(k) · Cleared
ClearedX-MIND trium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
De Gotzen S.R.L. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Nov 15, 2016 as substantially equivalent to K123381 (Cefla S.C., 2013) after a 293-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it.
- Decided
- Nov 15, 2016
- Review
- 293 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123381 (2013). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK123381 Hyperion X9Cefla S.C. · 2013
- This deviceK160166 X-MIND triumDe Gotzen S.R.L. · 2016
- Descendant · cites it directly · 0 of its ownK222666 X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023
- Descendant · cites it directly · 0 of its ownK201667 Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020
- Descendant · cites it directly · 0 of its ownK191719 X-MIND TriumDe Gotzen S.R.L. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123381 | Hyperion X9 | Cefla S.C. | 2013 | — |
| 0 (this device) | K160166 | X-MIND trium | De Gotzen S.R.L. | 2016 | — |
| +1 | K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023 | — |
| +1 | K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | 2020 | — |
| +1 | K191719 | X-MIND Trium | De Gotzen S.R.L. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K123381 | Hyperion X9Summary page 4…n name Computed tomography x-ray system Clearance date 05/10/2013 510(k) number K123381 page 1 of 29… | 2013 |
What descends from it? (3)
3 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. 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?
X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; -…
Read the full statement (167 words)
X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;
- producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm;
- producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
- producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.
From a clinical point of view, X-MIND trium can be applied for the following medical indications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology
The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.
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/K160166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160166: X-MIND trium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160166
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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