510(k) K974877 ยท EHD Unit, X-Ray, Extraoral With Timer
CRANEX TOME CEPH, OR CRANEX TOME
| Applicant | Orion Corporation Soredex, Helsinki, FI |
| Decision | Substantially Equivalent, Mar 27, 1998 |
| Received | Dec 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2007 | Instrumentarium Dental, Inc. Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland. Terminated |
EDH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.