510(k) K250781
- Device
- Embryo Predict
- Applicant
- Alife Health
- 510(k) number
- K250781
- Product code
- PBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-15
- Date received
- 2025-03-14
- Regulation
- 884.6195
- Classification name
- Embryo Image Assessment System, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Melissa Teran
- Address
- 16 Fayerweather St. Cambridge MA US 02138 02138
FDA Registration Numbers#
- 3042372505
- 3009107689
- 3042972064