Cleared Traditional

KIDScore D3

K182798 · Vitrolife A/S · Obstetrics & Gynecology
Jul 2019
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K182798 is an FDA 510(k) clearance for the KIDScore D3, 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 review panel. Regulated under 21 CFR 884.6195.

Submission Details

510(k) Number K182798 FDA.gov
FDA Decision Cleared 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

Device Classification

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 .