510(k) K981358 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
ARTOSCAN S
| Applicant | Biosound Esaote, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 13, 1998 |
| Received | Apr 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981358
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.