510(k) K112768 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
| Applicant | Calypso Medical Technologies, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Sep 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112768
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.