K242994
- 510(k) number
- K242994
- Device name
- OncoStudio (OS-01)
- Applicant
- Oncosoft. Co., Ltd. KR
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2025-02-24
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242994.pdf
Official FDA record: K242994
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.