510(k) K182138 ยท IYE Accelerator, Linear, Medical
Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
| Applicant | Eleckta Limited, Crawley, GB |
| Decision | Substantially Equivalent, Sep 5, 2018 |
| Received | Aug 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182138
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.