5 devices · 5 companies · 2006 to 2026
AI-enabled obstetrics and gynecology devices on FDA's list
5 devices in the Obstetrics and Gynecology panel, 2006 to 2026, from 5 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Obstetrics and Gynecology panel
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Embryo PredictK250781 · 510(k) | Alife Health | PBH | database entry | |
| CHLOE BLASTK243851 · 510(k) | Fairtility Ltd. | PBH | database entry | |
| PeriCALM Patterns 3.0K241009 · 510(k) | PeriGen, Inc. | HGM | database entry | |
| KIDScore D3K182798 · 510(k) | Vitrolife A/S | PBH | database entry | |
| LUMA CERVICAL IMAGING SYSTEMP040028 · PMA | SPECTRA SCIENCE | MWM | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.