3 devices · 3 companies · 2019 to 2026
Product code PBH: Embryo Image Assessment System, Assisted Reproduction
3 devices under product code PBH, 2019 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Embryo Image Assessment System, Assisted Reproduction. 21 CFR 884.6195, Class II. 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 . MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Embryo PredictK250781 · 510(k) | Alife Health | Obstetrics and Gynecology | database entry | |
| CHLOE BLASTK243851 · 510(k) | Fairtility Ltd. | Obstetrics and Gynecology | database entry | |
| KIDScore D3K182798 · 510(k) | Vitrolife A/S | Obstetrics and Gynecology | database entry |
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