K252084
- 510(k) number
- K252084
- Device name
- AI4CMR v2.0
- Applicant
- Ai4medimaging Medical Solutions S.A. PT
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-02-11
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252084.pdf
Official FDA record: K252084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.