K252298
- 510(k) number
- K252298
- Device name
- ANDI 2.0
- Applicant
- Imeka Solutions, Inc. CA
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-10-22
- Date received
- 2025-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252298.pdf
Official FDA record: K252298
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.