510(k) K161688 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Advanced Gynecological Applicator
| Applicant | Nucletron B.V., Veenendaal, NL |
| Decision | Substantially Equivalent, Jan 27, 2017 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Elekta, Inc. Brand Name: Brachytherapy Applicator
Product Name: Advanced Gynecological Applicator
Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for c Open, Classified |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.