# K133712: Embryoviewer Software

- Pathway: 510(k) (Traditional)
- Applicant: Unisense Fertilitech A/S
- Decided: Aug 8, 2014 after 246 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: 5 generations back to K040717 (2004). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113075: Embryo Viewer Software, Unisense Fertilitech A/S (2011) Summary page 2.

## Most influential descendants
- K173264: EmbryoScope+ (2018), 3 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
- K213869: EmbryoSlide+ ic8 dish (2022), 0 descendants of its own

## Indications for use
The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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. The EmbryoViewer™ software is an optional accessory software package for use in displaying, comparing, storing, and transferring images generated by the EmbryoScope® time-lapse incubator (Version D). The 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® time-lapse incubator (Version D).

Source page: https://510kreport.com/device/K133712
Methodology: https://510kreport.com/methodology