510(k) K152592 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAT-V
| Applicant | Hitachi, Ltd., Health Care Company, Tokyo, JP |
| Decision | Substantially Equivalent, Nov 2, 2015 |
| Received | Sep 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2019 | Hitachi America, Ltd., Power Systems Division PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.