510(k) · Cleared
Clearedeco-x Series (eco-x, eco-x-s)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdx Will Corp. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Dec 30, 2021 as substantially equivalent to K160140 (Hdx Will Corp., 2016) and 1 other predicate after a 255-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Dec 30, 2021
- Review
- 255 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K973598 (1997). 21 ancestors in all, the oldest K961826 (1996). No later device cites it as a predicate yet.
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK211159 eco-x Series (eco-x, eco-x-s)Hdx Will Corp. · 2021
Show all 9 generations
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 7 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 6 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 5 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 4 generations backK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK211159 eco-x Series (eco-x, eco-x-s)Hdx Will Corp. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −8 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −7 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −6 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −5 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −4 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −3 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −2 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| −1 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| 0 (this device) | K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | 2021 | — |
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 |
| 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K160140 | DENTRIa seriesSummary page 5…: Radiology 3. Predicate Device The predicate devices of the subject device are as follows; Predicate Device #1 K Number : K160140 Manufacturer : HDX WILL CORP.. Trade/Device Name : DENTRIα Series (DEN… | 2016 |
| * | K093590 | Planmeca Promax 3D MaxSummary page 6…: Computed tomography x-ray system Classification Panel : Radiology Predicate Device #2 K Number : K093590 Manufacturer : PLANMECA OY Trade/Device Name : PLANMECA PROMAX 3D MAX … | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 21 ancestors have a recall of any class.
- 3 other devices also cite its predicate K160140.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
‘eco-x series (eco-x, eco-x-s)’ is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.
In addition, ‘eco-x series’ is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211159 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211159: eco-x Series (eco-x, eco-x-s).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211159
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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