K253057
- 510(k) number
- K253057
- Device name
- AI-Rad Companion Brain MR
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-01-22
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253057.pdf
Official FDA record: K253057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.