510(k) · Cleared
ClearedRotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (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. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jul 6, 2017 as substantially equivalent to K090749 (Villa Sistemi Medicali S.P.A., 2009) after a 336-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 6, 2017
- Review
- 336 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961826 (1996). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK961826 DigipanTrophy Radiologie · 1996
- 3 generations backK983283 Signet Dxis Direct X-Ray Imaging SystemSignet Radiology, Inc. · 1998
- 2 generations backK041120 EV Apan Digital, Model K1VSM2000Afp Imaging Corp. · 2004
- 1 generation backK090749 Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
- This deviceK162190 Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX…Villa Sistemi Medicali S.P.A. · 2017
- Descendant · cites it directly · 1 of its ownK180601 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX…Villa Sistemi Medicali S.P.A. · 2018
- Descendant · 2 generations on · 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 2 of 2 · See all- K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A. · 2018 · cites it directly1descendant
- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961826 | Digipan | Trophy Radiologie | 1996 | — |
| −3 | K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | 1998 | — |
| −2 | K041120 | EV Apan Digital, Model K1VSM2000 | Afp Imaging Corp. | 2004 | — |
| −1 | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009 | — |
| 0 (this device) | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade… | Villa Sistemi Medicali S.P.A. | 2017 | — |
| +1 | K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under… | Villa Sistemi Medicali S.P.A. | 2018 | — |
| +2 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Summary page 4…mark Owandy Radiology) is compared with the following predicate device: Villa Sistemi Medicali Rotograph EVO D (K090749) - Regulation Number: 21 CFR 872.1800… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark… | 2018 | 1 |
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 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K180601 (Villa Sistemi Medicali S.P.A., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K090749.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and
oral structures.
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 as stated in the FDA summary.
https://510kreport.com/device/K162190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162190: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark 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/K162190
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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