Metrovision

Metrovision specializes in ophthalmic imaging technology, specifically the MonpackONE, which is a Vision Monitor. This device is designed for clinical use to evaluate retinal conditions and support eye health assessments through advanced imaging.

Metrovision is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in the U.S. market.

Metrovision’s MonpackONE Vision Monitor falls under the Class II category of medical devices as defined by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notification (510(k)) clearance.

Metrovision’s MonpackONE Vision Monitor is listed in the FDA’s 510(k) clearance registry, which documents devices that have undergone the pre-market notification process to demonstrate substantial equivalence to a legally marketed predicate device. This registry is a key reference for verifying regulatory status.