510(k) K032355 ยท EHD Unit, X-Ray, Extraoral With Timer
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
| Applicant | Dentsply Gendex, Des Plaines IL, US |
| Decision | Substantially Equivalent, Sep 25, 2003 |
| Received | Jul 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2011 | Gendex Dental Systems Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and Terminated |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.