EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations…
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.
Who Else Makes It
Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EmbryoScope+ | Listed by | Vitrolife A/S, Denmark |
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K173264 |
| Record published | 2018-05-24 |
| Record revised | 2026-04-27 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 80 to 106 KiloPascal; Storage environment temperature -10 to 50 °C; Storage environment humidity 30 to 80 % RH; Special storage condition: Keep dry; Special storage condition: < 2000 m above sea level (during operation); Handling environment humidity 0 to 85 % RH |
| Sizes | Weight 50 kg; height 50 cm; depth 60 cm; width 55 cm |
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.