K243849
- 510(k) number
- K243849
- Device name
- 2430TCA with Xmaru W
- Applicant
- Rayence Co., Ltd. KR
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2025-03-12
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243849.pdf
Official FDA record: K243849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.