Company ยท FR
Trophy
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2020. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2020 | K193390 | CS Model+ Trophy, FR | PNN |
| Mar 13, 2020 | K200183 | CS 9600 Trophy, FR | OAS |
| May 24, 2018 | K181136 | CS 9600 Trophy, FR | OAS |
| Jan 16, 2018 | K173622 | CS Imaging Trophy, FR | LLZ |
| Aug 21, 2015 | K151087 | CS 8100SC, CS8100SC Access Trophy, FR | MUH |
| Aug 19, 2015 | K151837 | CS 3D Imaging Trophy, FR | LLZ |
| Sep 18, 2014 | K141607 | DENTAL IMAGING SOFTWARE Trophy, FR | LLZ |
| Mar 14, 2014 | K133406 | CS 8100 3D Trophy, FR | OAS |
| Jun 22, 2012 | K120975 | CS 8100 CS 8100 ACCESS Trophy, FR | MUH |
| Feb 16, 2012 | K113419 | CS IMAGING Trophy, FR | LLZ |
| Aug 18, 2011 | K103659 | CS 9300, CS 9300C Trophy, FR | OAS |
| Apr 26, 2010 | K093478 | KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM Trophy, FR | MUH |
| Dec 5, 2008 | K082972 | KODAK 9500 Trophy, FR | MUH |
| Apr 29, 2008 | K080889 | KODAK 9000C EXTRAORAL IMAGING SYSTEM Trophy, FR | MUH |
| Feb 11, 2008 | K073435 | KODAK 9000, KODAK 9000 3D Trophy, FR | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2023 | Trophy SAS CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprof Open, Classified |
OAS | K181136 K200183 |
| May 2, 2013 | Trophy Sas CareStream Dental Kodak 2200 Intraoral 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 a Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental Kodak 2100 Intraoral 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 a Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental CS 2200 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 stru Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas 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 struc Terminated |
EAP | None listed |