510(k) K213370 ยท IYE Accelerator, Linear, Medical
VERIQA
| Applicant | Ptw-Freiburg Physikalisch-Technische-Werkstaetten, Freiburg, DE |
| Decision | Substantially Equivalent, Mar 30, 2022 |
| Received | Oct 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | PTW FREIBURG Brand Name: VERIQA;
Product Name: RT MonteCarlo 3D v3;
Model/Catalog Number: S070031.520;
Software Version: 3.1.18; Open, Classified |
IYE | None listed |
| Feb 22, 2024 | PTW-FREIBURG Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.