510(k) K051980 ยท JAK System, X-Ray, Tomography, Computed
DVT SCANNER
| Applicant | Imaging Sciences Intl., Inc., Hatfield PA, US |
| Decision | Substantially Equivalent, Aug 19, 2005 |
| Received | Jul 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2011 | Imaging Sciences International, LLC i-CAT Classic (X-Ray Tube head and Power Supply)
X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a de Terminated |
JAK | None listed |
| Dec 17, 2009 | Imaging Sciences International, LLC i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA.
To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contra Terminated |
JAK | None listed |
| Sep 1, 2008 | Imaging Sciences Intl Inc i-CAT Classic 3D Dental Imaging System Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.