510(k) · Cleared
ClearedImax Ceph Digital X-Ray Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owandy · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 14, 2006 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.
- Decided
- Nov 14, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK062403 Imax Ceph Digital X-Ray SensorOwandy · 2006
- Descendant · cites it directly · 30 of its ownK090749 Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
- Descendant · 2 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- Descendant · 3 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 4 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 4 generations on · 22 of its ownK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009 · cites it directly30descendants
- K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 2 generations on27descendants
- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 3 generations on24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 4 generations on23descendants
- K142247Rayscan a-Expert 3DRay Co., Ltd. · 2015 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062403 | Imax Ceph Digital X-Ray Sensor | Owandy | 2006 | — |
| +1 | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009 | — |
| +2 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| +3 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +4 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +4 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | 2009 | 30 |
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?
- Of its descendants, K090749 (Villa Sistemi Medicali S.P.A., 2009) has gone furthest, with 30 descendants of its own.
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.
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?
The IMAX CEPH digital X-ray sensor is intended
to capture extra oral x-ray images of a patient's head when exposed to X-rays for
diagnostic purposes.
The process is automatic and continues transmitting the digital image to a Personal
Computer VIA USB interface.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062403: Imax Ceph Digital X-Ray Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062403
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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