PBH — Embryo Image Assessment System, Assisted Reproduction Class II
FDA product code PBH covers "Embryo Image Assessment System, Assisted Reproduction", a Class II medical device regulated under 21 CFR 884.6195. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PBH
- Device Class
- Class II
- Regulation Number
- 884.6195
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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 .