510(k) K221000 ยท LLZ System, Image Processing, Radiological
ON3D
| Applicant | 3D Ons, Inc., Gangnam-Gu, KR |
| Decision | Substantially Equivalent, May 23, 2022 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221000
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.