510(k) K073059 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
| Applicant | Hitachi, Ltd., Power Systems Group, Washington DC, US |
| Decision | Substantially Equivalent, Dec 10, 2007 |
| Received | Oct 30, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073059
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2015 | Hitachi America, Ltd., Power Systems Division PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
Product Usage:
Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumo Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.