510(k) K201272 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Geneva
| Applicant | Nucletron B.V., Veenendaal, NL |
| Decision | Substantially Equivalent, Jul 16, 2020 |
| Received | May 12, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Elekta, Inc. Brand Name: Geneva
Product Name: Brachytherapy Applicator
Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional n Open, Classified |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.