510(k) K141900 ยท MUJ System, Planning, Radiation Therapy Treatment
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
| Applicant | Eckert & Ziegler Bebig GmbH, Veenendaal, NL |
| Decision | Substantially Equivalent, May 20, 2015 |
| Received | Jul 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2023 | Bebig Isotopentechnik Gmbh SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.