510(k) K201798 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
myQA iON
| Applicant | Iba Dosimetry GmbH, Schwarzenbruck, DE |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Jun 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201798
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2025 | IBA Dosimetry GmbH myQA iON; Article Number: MQ10-000; Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.