510(k) K061284 ยท MUH System, X-Ray, Extraoral Source, Digital
I-CAT SCANNER
| Applicant | Imaging Sciences Intl., Inc., Hatfield PA, US |
| Decision | Substantially Equivalent, Jul 3, 2006 |
| Received | May 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2009 | Imaging Sciences International, LLC Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation. Terminated |
MUH | None listed |
| Sep 1, 2008 | Imaging Sciences Intl Inc i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam Terminated |
MUH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.