510(k) · Cleared
ClearedCS 9300, CS 9300C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trophy · OAS X-Ray, Tomography, Computed, Dental
Cleared on Aug 18, 2011 after a 246-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Aug 18, 2011
- Review
- 246 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK103659 CS 9300, CS 9300CTrophy · 2011
- Descendant · cites it directly · 7 of its ownK160506 Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
- Descendant · cites it directly · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK181576 Planmeca VisoPlanmeca Oy · 2018
- Descendant · 3 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
- Descendant · cites it directly · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016 · cites it directly7descendants
- K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · cites it directly6descendants
- K181576Planmeca VisoPlanmeca Oy · 2018 · 2 generations on4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 3 generations on3descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103659 | CS 9300, CS 9300C | Trophy | 2011 | — |
| +1 | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016 | — |
| +1 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| +2 | K181576 | Planmeca Viso | Planmeca Oy | 2018 | — |
| +3 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| +1 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 164 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?
- Of its descendants, K160506 (Planmeca Oy, 2016) has gone furthest, with 7 descendants of its own.
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. 2011, 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 CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103659: CS 9300, CS 9300C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103659
Report an extraction error
Are you the manufacturer?
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