Data / Medical devices / France / Trophy
Trophy: FDA-registered device maker in Marne La Vallee Ile-de-France, France, 11 510(k) clearances and 1 PMA approval
Trophy is registered with the FDA (registration 8020825) in Marne La Vallee Ile-de-France, France. It lists 7 device types. The FDA files 11 510(k) clearances and 1 PMA approval under its listings, the newest dated March 13, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020825
- FEI number
- 7695
- Address
- 4 rue F. Pelloutier CROISSY- BEAUBOURG, Marne La Vallee Ile-de-France, France, 77435
- Owner or operator
- Carestream Dental LLC (10056540)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 20, 2017
- Registered through
- 2026
- Brand names listed
- CEPHALOSTAT, CS 1300, CS 2100, CS 2200, CS 3D Imaging Software, CS 8100, CS 8100 3D, CS 8100 3D Access and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Intraoral | EAP | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2020 | K200183 | CS 9600 | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| May 24, 2018 | K181136 | CS 9600 | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| January 16, 2018 | K173622 | CS Imaging | LLZ | Substantially Equivalent | Trophy | accessdata.fda.gov |
| August 21, 2015 | K151087 | CS 8100SC, CS8100SC Access | MUH | Substantially Equivalent | Trophy | accessdata.fda.gov |
| August 19, 2015 | K151837 | CS 3D Imaging | LLZ | Substantially Equivalent | Trophy | accessdata.fda.gov |
| March 14, 2014 | K133406 | CS 8100 3D | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| June 22, 2012 | K120975 | CS 8100 CS 8100 ACCESS | MUH | Substantially Equivalent | Trophy | accessdata.fda.gov |
| August 18, 2011 | K103659 | CS 9300, CS 9300C | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| April 26, 2010 | K093478 | KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM | MUH | Substantially Equivalent | Trophy | accessdata.fda.gov |
| March 3, 2006 | K060292 | KODAK MODELS 2100 AND 2200 | EHD | Substantially Equivalent | Kodak-Trophy | accessdata.fda.gov |
| April 19, 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | EAP | Substantially Equivalent | Trophy Radiologie | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 25, 1998 | P980025 | LOGICON CARIES DETECTOR | MYN | 4 | September 5, 2019 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 21, 2021 | 92206 | Class II | Ongoing | CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosti | Device failed to function as intended and/or failed to conform to their design specifications. | accessdata.fda.gov |
| September 18, 2012 | 64589 | Class II | Terminated | CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of System, Image Processing, Radiological
- All makers of Camera, Surgical And Accessories
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Unit, X-Ray, Intraoral
- All makers of X-Ray, Tomography, Computed, Dental
Updated May 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.