510(k) K050255 ยท EHD Unit, X-Ray, Extraoral With Timer
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
| Applicant | Gendex Dental Systems, Des Plaines IL, US |
| Decision | Substantially Equivalent, Mar 17, 2005 |
| Received | Feb 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2011 | Gendex Dental Systems Orthoralix 8500 DDE Panoramic 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 110-0234G3.
The Terminated |
EHD | None listed |
| Feb 18, 2011 | Gendex Dental Systems Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international)
The O Terminated |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.