K250781
- 510(k) number
- K250781
- Device name
- Embryo Predict
- Applicant
- Alife Health MA · US
- Product code
- PBH — Embryo Image Assessment System, Assisted Reproductio
- Decision date
- 2026-05-15
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250781.pdf
Official FDA record: K250781
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.