510(k) · Cleared
Recalled · Class II · 2015Rotograph Evo 3D
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 22, 2011 as substantially equivalent to K090749 (Villa Sistemi Medicali S.P.A., 2009) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1997. 27 later devices descend from it. It has been recalled once.
- Decided
- Jul 22, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- MUH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K973598 (1997). 15 ancestors in all, the oldest K961826 (1996). 27 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 2 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 1 generation backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- This deviceK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011
- Descendant · cites it directly · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 2 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 2 generations on · 22 of its ownK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- Descendant · 2 generations on · 11 of its ownK160525 RCT700Ray Co., Ltd. · 2016
- Descendant · 3 generations on · 10 of its ownK181452 RCT800Ray Co., Ltd. · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · cites it directly24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 2 generations on23descendants
- K142247Rayscan a-Expert 3DRay Co., Ltd. · 2015 · 2 generations on22descendants
- K160525RCT700Ray Co., Ltd. · 2016 · 2 generations on11descendants
- K181452RCT800Ray Co., Ltd. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −2 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −1 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| 0 (this device) | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | — |
| +1 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +2 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +2 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| +2 | K160525 | RCT700 | Ray Co., Ltd. | 2016 | — |
| +3 | K181452 | RCT800 | Ray Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Summary page 1…The Rotograph EVO 3D iscompared with the following predicate devices: * Villa Sistemni Medicali Rotograph EVO D(K090749), * Planmeca PmMax 3D (K060328). Product Desctiaton: Rotograph EVO 3D is… | 2009 |
| * | K060328 | Planmeca Promax 3DSummary page 1…ate devices: * Villa Sistemni Medicali Rotograph EVO D(K090749), * Planmeca PmMax 3D (K060328). Product Desctiaton: Rotograph EVO 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped… | 2006 |
What descends from it? (27)
See all 272 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2015 | Class II | Z-0128-2016 | Other | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K122981 (Ray Co., Ltd., 2013) has gone furthest, with 24 descendants 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. 2011, 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 EVO 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth. jaw, and oral structures, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel…
Read the full statement (111 words)
Rotograph EVO 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth. jaw, and oral structures, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111152: Rotograph Evo 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111152
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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