510(k) K160882 ยท OAS X-Ray, Tomography, Computed, Dental
PaX-i3D Green Premium (Model: PCT-90LH)
| Applicant | VATECH Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Oct 28, 2016 |
| Received | Mar 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160882
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.