InVision is an FDA registered Class I medical device. It does not diagnose or recognize lymph nodes or any other anatomical structures. It is a phase-contrast microscope that provides contrast between different tissue types based on how they change the phases of light propagation. It does not diagnose or recognize lymph nodes for the users, and users ultimately make the final judgement on whether a specific piece of specimen contains lymph nodes or not. It is intended to be used by trained healthcare professionals in clinical environments and cannot be used at home.
InVision is also certified for IEC 61010-1:2010 (Safety requirements for electrical equipment for measurement, control, and laboratory use) and IEC 61326-1:2012 (immunity and emissions regarding electromagnetic compatibility (EMC) for electrical equipment, operating from a supply or battery of less than 1000 V a.c. or 1500 V d.c. or from the circuit being measured.) The users should follow InVision’s manual and instruction videos to operate the device. The user should not directly look at the illumination source in InVision with their eyes for an extended period of time to prevent any eye damage. Specimens should not be left on the imaging window for an extended period as extensive exposure to light can potentially dehydrates and damage the specimen.
For important safety information, please also refer to www.cisionvision/product. For a product’s intended use and/or indications for use, risks, full cautions and warnings, please refer to the associated User Manual(s).
Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, and/or user experience.