K260528
- 510(k) number
- K260528
- Device name
- OncoStudio
- Applicant
- Oncosoft. Inc., KR
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2026-07-02
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K260528.pdf
Official FDA record: K260528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.