Embryo Image Assessment System, Assisted Reproduction
Product Code: PBH
Obstetrics/Gynecology General Optical Products / Medical
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.
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Code of Federal Regulations: 884.6195
| Radiation Type | Optical |
| Radition Safety | None |
| Annual Reports | No |