510(k) · Cleared
Recalled · 2011Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161WW, 5105 0181WW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Gendex · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 25, 2003 after a 57-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 25, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032355 Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105…Dentsply Gendex · 2003
- Descendant · cites it directly · 0 of its ownK101661 Myray HyperionCefla Dental Group · 2010
Most influential descendants
Showing 1 of 1 · See all- K101661Myray HyperionCefla Dental Group · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032355 | Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161WW, 5105… | Dentsply Gendex | 2003 | — |
| +1 | K101661 | Myray Hyperion | Cefla Dental Group | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Gendex Orthoralix 9200 and 9200 Plus Named without a submission number | |
| * | — | Instrumentarium Orthoceph® OC 100 D Direct Digital Cephalometric Imaging System Named without a submission number | |
| * | — | Planmeca DIMAX2 Direct Digital Imaging System Named without a submission number | |
| * | — | Sirona Orthophos Plus 13S Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101661 | Myray Hyperion | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2011 | Not classified | Z-2041-2011 | Other | There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101661 (Cefla Dental Group, 2010) has gone furthest, with 0 descendants of its own.
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.
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?
The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-
maxilofacial area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032355: Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161WW, 5105 0181WW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032355
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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