510(k) K163423 ยท OAS X-Ray, Tomography, Computed, Dental
Orthopantomograph OP300
| Applicant | Palodex Group OY, Tuusula, FI |
| Decision | Substantially Equivalent, Aug 31, 2017 |
| Received | Dec 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Palodex Group Oy Orthopantomograph OP300 dental computed tomography x-ray system.
The X-ray device produces conventional 2D X-ray images and Xray
projection images for the reconstruction of a 3D view. The device is o Open, Classified |
OAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.