| Device |
embryo image assessment system, assisted reproduction |
| Regulation Description |
Assisted Reproduction Embryo Image Assessment System. |
| 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 . |
| 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 Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | PBH |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
884.6195
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
