K182798 is an FDA 510(k) clearance for the KIDScore D3. This device is classified as a Embryo Image Assessment System, Assisted Reproduction (Class II - Special Controls, product code PBH).
Submitted by Vitrolife A/S (Viby J, DK). The FDA issued a Cleared decision on July 19, 2019, 290 days after receiving the submission on October 2, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6195. 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 ..
| 510(k) Number | K182798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2018 |
| Decision Date | July 19, 2019 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBH - Embryo Image Assessment System, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6195 |
| 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 . |