K233539
- 510(k) number
- K233539
- Device name
- MAMMOMAT B.brilliant
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2024-03-27
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233539.pdf
Official FDA record: K233539
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.