K251528
- 510(k) number
- K251528
- Device name
- syngo.via MI Workflows; Scenium; syngo MBF
- Applicant
- Siemens Medical Solutions USA, Inc. IL · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-07-03
- Date received
- 2025-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K251528.pdf
Official FDA record: K251528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.