# K113075: Embryo Viewer Software

- Pathway: 510(k) (Traditional)
- Applicant: Unisense Fertilitech A/S
- Decided: Dec 21, 2011 after 65 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: 4 generations back to K040717 (2004). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092183: Embryoscope and Embryoslide, Unisense Fertilitech A/S (2011) Summary page 2.
- K111715: Embryoscope, Unisense Fertilitech A/S (2011) Summary page 2.

## Most influential descendants
- K133712: Embryoviewer Software (2014), 4 descendants of its own
- K173264: EmbryoScope+ (2018), 3 descendants of its own
- K171736: Geri Embryo Incubator and Geri Dish (2017), 2 descendants of its own
- 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

## Indications for use
The EmbryoScope (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development. EmbryoViewer is an optional accessory software package for use in displaying, comparing, storing, and transferring EmbryoScope (Version D) generated images. The software includes a user annotation function for capturing information on embryo development parameters, treatment data, and outcome data. The EmbryoViewer software does not control any hardware components in the EmbryoScope (Version D) device.

Source page: https://510kreport.com/device/K113075
Methodology: https://510kreport.com/methodology