510(k) K133191 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAM PROTON THERAPY SYSTEM
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Jan 10, 2014 |
| Received | Oct 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2014 | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH ProBeam Proton Therapy System (HGA and HFB)
Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radi Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.