K252634
- 510(k) number
- K252634
- Device name
- Imagine® Enterprise Suite
- Applicant
- Softlink International Private Limited IN
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-01-16
- Date received
- 2025-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252634.pdf
Official FDA record: K252634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.