PBH

Embryo Image Assessment System, Assisted Reproduction

Product code

PBH

Device name

Embryo Image Assessment System, Assisted Reproduction

Device class

Class 2

21 CFR

21 CFR 884.6195

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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 .

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-15.

2 summaries are archived here for direct download.