K253704
- 510(k) number
- K253704
- Device name
- iPredict-DR
- Applicant
- iHealthscreen, Inc. NY · US
- Product code
- PIB — Diabetic Retinopathy Detection Device
- Decision date
- 2026-07-02
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253704.pdf
Official FDA record: K253704
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.