K261405
- 510(k) number
- K261405
- Device name
- ANDI 2.2
- Applicant
- Imeka Solutions, Inc. CA
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-05-28
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261405.pdf
Official FDA record: K261405
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.