510(k) K250781
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2026
- Date Received
- March 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Embryo Image Assessment System, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6195
- Review Panel
- OB
- Submission Type
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .