510(k) · Cleared
ClearedX-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
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 18, 2020 as substantially equivalent to K180601 (Villa Sistemi Medicali S.P.A., 2018) and 1 other predicate after a 176-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Nov 18, 2020
- Review
- 176 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K973598 (1997). 32 ancestors in all, the oldest K961826 (1996). No later device cites it as a predicate yet.
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 2 generations backK160140 DENTRIa seriesHdx Will Corp. · 2016
- 1 generation backK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
- This deviceK201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark…De Gotzen S.R.L. · 2020
Show all 10 generations
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 8 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 7 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 6 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 5 generations backK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 4 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 3 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 2 generations backK160140 DENTRIa seriesHdx Will Corp. · 2016
- 1 generation backK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
- This deviceK201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark…De Gotzen S.R.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −9 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −8 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −7 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −6 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −5 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −4 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −3 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| −2 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| −1 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018 | — |
| 0 (this device) | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy… | De Gotzen S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Summary page 5…Regulation number 892.1750 Regulation name Computed tomography x-ray system Clearance date November 2nd, 2018 510(k) number K180601 Table 3: Primary predicate device information Rev. n. 2… | 2018 |
| * | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S)Summary page 6…lation number 872.1800 Regulation name Extraoral source x-ray system Clearance date November 21st, 2018 510(k) number K181297 Table 4: Additional predicate device information IV. DEVICE DESCRIPTION NOTE: In the following, all the reference to X-MI… | 2018 |
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 23 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 32 ancestors have a recall of any class.
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?
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the…
Read the full statement (166 words)
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).
The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].
Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201382: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201382
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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