510(k) · Cleared
ClearedX-View 3D Pan/X-View 2D Pan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trident S.R.L · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jul 10, 2023 as substantially equivalent to K160166 (De Gotzen S.R.L., 2016) and 1 other predicate after a 307-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Jul 10, 2023
- Review
- 307 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K973598 (1997). 19 ancestors in all, the oldest K930338 (1993). 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 backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- 2 generations backK122806 Image Works PanouraMic International · 2013
- 1 generation backK182198 Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd. · 2019
- This deviceK222666 X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023
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 backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 4 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 3 generations backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- 2 generations backK122806 Image Works PanouraMic International · 2013
- 1 generation backK182198 Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd. · 2019
- This deviceK222666 X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023
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 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −4 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −3 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| −2 | K122806 | Image Works Panoura | Mic International | 2013 | — |
| −1 | K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019 | — |
| 0 (this device) | K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K160166 | X-MIND triumSummary page 4…Radiology Regulation Class: II Product Code: OAS Submission Type: 510(k) III. Predicate Device 510(k) Number: K160166 Date Cleared: November 15, 2016 Manufacturer: de Gotzen S.r.l. Trade Name: X-MIND tri… | 2016 |
| * | K182198 | Panoura X-ERA PF/NF/MFSummary page 5…892.1750 Medical Specialty: Radiology Regulatory Class: II Product Code: OAS, MUH Secondary Predicate 510(k) Number: K182198 Date Cleared: January 31, 2019 Manufacturer: Yoshida Dental Mfg. Co., Ltd. Trade Name:… | 2019 |
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 26 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160166.
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. 2023, 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?
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.
The device must only be operated and used by dentists and other legally qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222666: X-View 3D Pan/X-View 2D Pan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222666
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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