The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function…
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 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.
Who Else Makes It
Concentrated in Guangdong (2), Hubei (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EmbryoViewer | Listed by | Vitrolife A/S, Denmark |
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K113075 |
| Record published | 2026-04-16 |
| Record revised | 2026-04-27 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.