510(k) · Cleared
Recalled · Class II · 2021CS 9600
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 May 24, 2018 as substantially equivalent to K160506 (Planmeca Oy, 2016) after a 24-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- May 24, 2018
- Review
- 24 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973598 (1997). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 4 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 3 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 2 generations backK093590 Planmeca Promax 3D MaxPlanmeca Oy · 2010
- 1 generation backK160506 Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
- This deviceK181136 CS 9600Trophy · 2018
- Descendant · cites it directly · 0 of its ownK200183 CS 9600Trophy · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200183CS 9600Trophy · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −5 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −4 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −3 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −2 | K093590 | Planmeca Promax 3D Max | Planmeca Oy | 2010 | — |
| −1 | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016 | — |
| 0 (this device) | K181136 | CS 9600 | Trophy | 2018 | — |
| +1 | K200183 | CS 9600 | Trophy | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K160506 | Planmeca ProMax 3D Max, Planmeca MaximitySummary page 4…function to the following device introduced into commercial distribution after May 28, 1976: Trade/Device Name: Planmeca ProMax 3D Max, Planmeca Maximity 510(k) Number: K160506 Date of clearance: May 20, 2016 Regulation number: 892.1750 Regulation name (classification name): Computed tomography x‐ray syst… | 2016 |
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 |
|---|---|---|---|
| K200183 | CS 9600 | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2021 | Class II | Z-1627-2023 | Radiation Control for Health and Safety Act | Device failed to function as intended and/or failed to conform to their design specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K200183 (Trophy, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160506.
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. 2018, 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 9600 is extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181136: CS 9600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181136
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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