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 .
| Device Type ID | 4076 |
| Device Name | Embryo Image Assessment System, Assisted Reproduction |
| Physical State | Optical Imaging System And Analysis Software |
| Technical Method | Imaging System That 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 |
| Target Area | Human Embryos |
| Regulation Description | Assisted Reproduction Embryo Image Assessment System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.6195 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4076 |
| Device | Embryo Image Assessment System, Assisted Reproduction |
| Product Code | PBH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Embryo Image Assessment System. |
| CFR Regulation Number | 884.6195 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AUXOGYN, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |