510(k) K243851

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 15, 2025

Date Received

December 16, 2024

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 .