510(k) · Cleared
ClearedRoograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Villa Sistemi Medicali S.P.A. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on May 18, 2009 as substantially equivalent to K002432 (Villa Sistemi Medicali S.P.A., 2000) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1996. 30 later devices descend from it.
- Decided
- May 18, 2009
- Review
- 59 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961826 (1996). 8 ancestors in all. 30 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK961826 DigipanTrophy Radiologie · 1996
- 2 generations backK983283 Signet Dxis Direct X-Ray Imaging SystemSignet Radiology, Inc. · 1998
- 1 generation backK041120 EV Apan Digital, Model K1VSM2000Afp Imaging Corp. · 2004
- This deviceK090749 Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
- Descendant · cites it directly · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- Descendant · 2 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 3 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 3 generations on · 22 of its ownK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- Descendant · 3 generations on · 11 of its ownK160525 RCT700Ray Co., Ltd. · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · cites it directly27descendants
- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 2 generations on24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 3 generations on23descendants
- K142247Rayscan a-Expert 3DRay Co., Ltd. · 2015 · 3 generations on22descendants
- K160525RCT700Ray Co., Ltd. · 2016 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961826 | Digipan | Trophy Radiologie | 1996 | — |
| −2 | K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | 1998 | — |
| −1 | K041120 | EV Apan Digital, Model K1VSM2000 | Afp Imaging Corp. | 2004 | — |
| 0 (this device) | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009 | — |
| +1 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| +2 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +3 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +3 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| +3 | K160525 | RCT700 | Ray Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K002432 | Strato XSummary page 1…graph EVO and Rotograph EVO D are compared with the following predicate devices: * Villa Sistemi Medicali Strato X- model Strato 2000 (K002432), villa Sistemi Medicali Strato X- model Strato 2000 Digital (K002432),… | 2000 |
| * | K041120 | EV Apan Digital, Model K1VSM2000Summary page 1…villa Sistemi Medicali Strato X- model Strato 2000 Digital (K002432), * AFP/Owandy EVApan Digital/KIVSM2000 dental panoramic sensor (K041120), * Owandy IMAX CEPH digital X-ray sensor (K062403). Product Description: Rotograph EV… | 2004 |
| * | K062403 | Imax Ceph Digital X-Ray SensorSummary page 1…* AFP/Owandy EVApan Digital/KIVSM2000 dental panoramic sensor (K041120), * Owandy IMAX CEPH digital X-ray sensor (K062403). Product Description: Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either… | 2006 |
What descends from it? (30)
See all 303 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)
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 13 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K111152 (Villa Sistemi Medicali S.P.A., 2011) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K002432.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090749
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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