510(k) · Cleared
Recalled · 2011Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gendex Dental Systems · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Mar 17, 2005 after a 42-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 17, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050255 Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4Gendex Dental Systems · 2005
- Descendant · cites it directly · 0 of its ownK091866 Progeny Vantage Panoramic X-Ray SystemMidmark · 2009
Most influential descendants
Showing 1 of 1 · See all- K091866Progeny Vantage Panoramic X-Ray SystemMidmark · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050255 | Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 | Gendex Dental Systems | 2005 | — |
| +1 | K091866 | Progeny Vantage Panoramic X-Ray System | Midmark | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 Named without a submission number | |
| * | — | Planmeca DIMAX2 Named without a submission number | |
| * | — | Gendex Orthoralix 9200 DDE Named without a submission number | |
| * | — | Gendex GX-9000 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 |
|---|---|---|---|
| K091866 | Progeny Vantage Panoramic X-Ray System | 2009 | 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-2040-2011 | 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… |
| Dec 21, 2010 | Not classified | Z-1373-2011 | Labeling Change Control | The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091866 (Midmark, 2009) 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 8500 Panoramic 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/K050255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050255: Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050255
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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