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 Mar 13, 2020 as substantially equivalent to K181136 (Trophy, 2018) after a 49-day review. Its family tree reaches back 7 generations to 1997. It has been recalled once.
- Decided
- Mar 13, 2020
- Review
- 49 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973598 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 backK093590 Planmeca Promax 3D MaxPlanmeca Oy · 2010
- 2 generations backK160506 Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
- 1 generation backK181136 CS 9600Trophy · 2018 · Recalled
- This deviceK200183 CS 9600Trophy · 2020
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 | K093590 | Planmeca Promax 3D Max | Planmeca Oy | 2010 | — |
| −2 | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016 | — |
| −1 | K181136 | CS 9600 | Trophy | 2018 | 1 |
| 0 (this device) | K200183 | CS 9600 | Trophy | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K181136 | CS 9600Summary page 5…roduced into commercial distribution after May 28, 1976: Primary Predicate Device 510(k) Company Name Name CS 9600 K181136 Trophy Regulation number: 21 CFR 892.1750 Regulation name (classification name): Computed tomography x-ray sy… | 2018 |
| † | K151087 | CS 8100SC, CS8100SC Access | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
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. 2020, 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.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
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/K200183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200183: 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/K200183
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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