510(k) · Cleared
ClearedPREXION3D Eclipse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Yoshida Dental Mfg. Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 18, 2013 as substantially equivalent to K063622 (The Yoshida Dental Mfg. Co., Ltd., 2007) and 2 other predicates after a 268-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it.
- Decided
- Apr 18, 2013
- Review
- 268 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K973598 (1997). 19 ancestors in all, the oldest K930338 (1993). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 5 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 4 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 3 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 2 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 1 generation backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- This deviceK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
- Descendant · cites it directly · 2 of its ownK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
- Descendant · 2 generations on · 1 of its ownK210820 EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021
- Descendant · 2 generations on · 1 of its ownK173878 PreXion3D ExcelsiorPrexion Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK223816 Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · cites it directly2descendants
- K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016 · cites it directly2descendants
- K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021 · 2 generations on1descendant
- K173878PreXion3D ExcelsiorPrexion Corporation · 2018 · 2 generations on1descendant
- K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −6 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −5 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −4 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −3 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −2 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −1 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| 0 (this device) | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| +1 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +1 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016 | — |
| +2 | K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021 | — |
| +2 | K173878 | PreXion3D Excelsior | Prexion Corporation | 2018 | — |
| +3 | K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K063622 | Finecube Dental CTSummary page 2…tantially equivalent to the following legally marketed device: 510(k)*Number Trade name Product code K063622 FINECUBE OAS K103659 CS 9300 OA… | 2007 |
| * | K103659 | CS 9300, CS 9300CSummary page 2…510(k)*Number Trade name Product code K063622 FINECUBE OAS K103659 CS 9300 OAS K111231 PANOURA18SS MU… | 2011 |
| * | K111231 | Panoura 18SSummary page 2…K063622 FINECUBE OAS K103659 CS 9300 OAS K111231 PANOURA18SS MUll The predicate devices are hereinafter called "the FINECUBE (k063622)… | 2011 |
What descends from it? (6)
2 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 16 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K161881 (Prexion Corporation, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K063622.
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. 2013, 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?
PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.
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/K122199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122199: PREXION3D Eclipse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122199
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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