510(k) · Cleared
ClearedX-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
De Götzen S.R.L. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 5, 2021 as substantially equivalent to K090749 (Villa Sistemi Medicali S.P.A., 2009) after an 81-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Feb 5, 2021
- Review
- 81 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. No later device cites it as a predicate yet.
- 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 deviceK203374 X-MIND prime (under trade mark Acteon), I-MAX (under trade mark…De Götzen S.R.L. · 2021
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) | K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy… | De Götzen S.R.L. | 2021 | — |
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 |
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 5…872.1800 Regulation name Extraoral source x-ray system Clearance date May 18th, 2009 510(k) number K090749 Table 3: Predicate device information Rev. n. 2 V… | 2009 |
| † | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | 2018 |
| † | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark… | 2017 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 9 ancestors has a recall.
- 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. 2021, 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?
X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMJ and sinus exams). 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. The device is operated and used by…
Read the full statement (129 words)
X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMJ and sinus exams). 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. 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/K203374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203374: X-MIND prime (under trade mark Acteon), I-MAX (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/K203374
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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