K253835
- 510(k) number
- K253835
- Device name
- Affinity
- Applicant
- Hermes Medical Solutions AB SE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-07-31
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253835.pdf
Official FDA record: K253835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.