K262383
- 510(k) number
- K262383
- Device name
- LumenCare Azure
- Applicant
- Nucletron B.V. NL
- Product code
- JAQ — System, Applicator, Radionuclide, Remote-Controlled
- Decision date
- 2026-07-24
- Date received
- 2026-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K262383.pdf
Official FDA record: K262383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.