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Embryo Image Assessment System, Assisted Reproduction

FDA product code PBH · 3 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.6195
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-19 – 2026-05-15

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 .

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