Device typeAssisted reproduction incubator/microscope camera system: An assembly of mains electricity (AC-powered) devices intended to be used during assisted reproduction/in vitro fertilization (IVF) to incubate reproductive biological materials (e.g., gametes and embryos) at closely regulated and monitored temperatures, whilst acquiring, processing, and storing images of the embryo cultures, over the course of development, to assist embryo selection. It consists of an incubator with a built-in digital microscope still camera, monitor, and software; it may include additional supportive devices (e.g., printer). The system may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentrations].
FDA categoryAccessory, Assisted Reproduction
Device ID05712714603013
Catalog numberESD20000
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information