510(k) K190812 ยท OAS X-Ray, Tomography, Computed, Dental
RAYSCAN a-Expert3D
| Applicant | Ray Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Apr 24, 2019 |
| Received | Mar 29, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190812
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.