510(k) K181498 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
X-ray Imaging System for the McLaren Proton Treatment System
| Applicant | Ehmetdx, LLC, Plymouth MI, US |
| Decision | Substantially Equivalent, Dec 10, 2018 |
| Received | Jun 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181498
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.