510(k) K250429 · IYE Accelerator, Linear, Medical
DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask
| Applicant | Macromedics BV, Moordrecht, NL |
| Decision | Substantially Equivalent, Mar 19, 2025 |
| Received | Feb 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250429
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.