510(k) K121400 ยท OAS X-Ray, Tomography, Computed, Dental
PAX-UNI3D, PHT-7500
| Applicant | VATECH Co., Ltd., Houston TX, US |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | May 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121400
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.