510(k) K181136 ยท OAS X-Ray, Tomography, Computed, Dental
CS 9600
| Applicant | Trophy, Croissy-Beaubourg, FR |
| Decision | Substantially Equivalent, May 24, 2018 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181136
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.