K241113
- 510(k) number
- K241113
- Device name
- VIVIX-M
- Applicant
- Vieworks Co., Ltd. KR
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2025-01-16
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K241113.pdf
Official FDA record: K241113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.