K251037
- 510(k) number
- K251037
- Device name
- Rectal Applicator
- Applicant
- Nucletron B.V. NL
- Product code
- JAQ — System, Applicator, Radionuclide, Remote-Controlled
- Decision date
- 2025-12-19
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251037.pdf
Official FDA record: K251037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.