Devices · Vitrolife A/S

KIDScore D3

Vitrolife A/S is listed for KIDScore D3 (K182798). The FDA list gives July 19, 2019 as the date of the final decision. The lead panel is Obstetrics and Gynecology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PBH as “Embryo Image Assessment System, Assisted Reproduction”: 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 . openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182798

Official FDA database record

Date of final decision

July 19, 2019

Company on the FDA list

Vitrolife A/S

Lead panel

Obstetrics and Gynecology

Primary product code

PBH

openFDA device name for the code

Embryo Image Assessment System, Assisted Reproduction

Device class

2

Regulation number

884.6195

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary