510(k) · Cleared
ClearedRotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Villa Sistemi Medicali S.P.A. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Nov 2, 2018 as substantially equivalent to K130443 (Owandy, 2013) and 1 other predicate after a 240-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Nov 2, 2018
- Review
- 240 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K973598 (1997). 18 ancestors in all, the oldest K961826 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 4 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 3 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 2 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 1 generation backK130443 I-Max Touch 3DOwandy · 2013 · Recalled
- This deviceK180601 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX…Villa Sistemi Medicali S.P.A. · 2018
- Descendant · cites it directly · 0 of its ownK201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark…De Gotzen S.R.L. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −5 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −4 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −3 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −2 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −1 | K130443 | I-Max Touch 3D | Owandy | 2013 | 1 |
| 0 (this device) | K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under… | Villa Sistemi Medicali S.P.A. | 2018 | — |
| +1 | 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 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K130443 | I-Max Touch 3DSummary page 4…I-MAX Touch 3D Manufacturer: Owandy Radiology 510(k) clearance: K130443 (June 14, 2013) Device Type: x-ray, tomography, computed, dental… | 2013 |
| * | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark…Summary page 5…tograph Prime Manufacturer: Villa Sistemi Medicali S.p.A. 510(k) clearance: K162190 (July 6, 2017) Device Type: System, x-ray, extraoral source, digital… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | 2020 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K201382 (De Gotzen S.R.L., 2020) has gone furthest, with 0 descendants of its own.
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. 2018, 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?
Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.
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 devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
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/K180601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180601: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180601
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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