# K173264: EmbryoScope+

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife A/S
- Decided: May 11, 2018 after 212 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K040717 (2004). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133712: Embryoviewer Software, Unisense Fertilitech A/S (2014) Summary page 4.
- K150961: EmbryoSlide Culture Dish, Vitrolife A/S (2015) Summary page 4.

## Most influential descendants
- K242684: Harioculture TL-16 Time-lapse Incubator (2025), 0 descendants of its own
- K232493: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (2024), 0 descendants of its own
- K213869: EmbryoSlide+ ic8 dish (2022), 0 descendants of its own

## Indications for use
EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

Source page: https://510kreport.com/device/K173264
Methodology: https://510kreport.com/methodology