Product code PBH

Device name

Embryo Image Assessment System, Assisted Reproduction

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.6195

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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 .

Source

FDA openFDA device classification dataset