K243045
- 510(k) number
- K243045
- Device name
- BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
- Applicant
- Braxx Biotech Co., Ltd. TW
- Product code
- JAQ — System, Applicator, Radionuclide, Remote-Controlled
- Decision date
- 2024-11-19
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243045.pdf
Official FDA record: K243045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.