510(k) K243045 · JAQ System, Applicator, Radionuclide, Remote-Controlled
BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
| Applicant | Braxx Biotech Co., Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Nov 19, 2024 |
| Received | Sep 27, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243045
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.