K251351
- 510(k) number
- K251351
- Device name
- AccuContour 4.0
- Applicant
- Manteia Technologies Co., Ltd. CN
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2026-01-23
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251351.pdf
Official FDA record: K251351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.