K242818
- 510(k) number
- K242818
- Device name
- IsoSphere
- Applicant
- Isoaid, LLC FL · US
- Product code
- KXK — Source, Brachytherapy, Radionuclide
- Decision date
- 2025-07-15
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K242818.pdf
Official FDA record: K242818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.