510(k) K160405 ยท IYE Accelerator, Linear, Medical
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
| Applicant | Ptw-Freiburg Physikalisch-Technische-Werkstaetten, Freiburg, DE |
| Decision | Substantially Equivalent, Oct 20, 2017 |
| Received | Feb 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2023 | PTW-FREIBURG BeamAdjust software Version 2.3.3
Ref: S080032
The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ):
" OC Open, Classified |
IYE | None listed |
| Aug 27, 2021 | PTW NORTH AMERICA CORPORATION Software BeamAdjust version 2.2, Catalog No: S070009
Software VeriSoft version 8.0, Catalog No: S080032 Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.