K250780
- 510(k) number
- K250780
- Device name
- ARTAssistant
- Applicant
- Manteia Technologies Co., Ltd. CN
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2025-12-05
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250780.pdf
Official FDA record: K250780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.