SIVIEWExam® is a Class IIa medical device (No. 0051) that complies with Regulation (EU) 2017/745 on medical devices. SIVIEWExam® is clinical decision-support software that enables users to perform an automated eye exam, verify and/or quickly obtain a subject’s best subjective refraction, and then record the results in a consultation report. Use of the device is restricted to healthcare professionals authorized to perform eye exams or to delegate such exams. This medical device is not covered by health insurance providers. Please read the provided user manuals carefully before use.
This medical device is a regulated health product that bears the CE mark in accordance with these regulations.
SIVIEWBox® is a Class I medical device accessory that complies with Regulation (EU) 2017/745 on medical devices. SIVIEWBox® is a connection box that interfaces the SIVIEWExam® application with refraction instruments in a medical office or retail location to ensure communication with and control of the ophthalmic equipment used during eye exams. Use of the device is restricted to healthcare professionals or installers authorized by SIVIEW. This medical device is not covered by health insurance providers. Please read the provided user manuals carefully before use.
This medical device is a regulated health product that bears the CE mark in accordance with these regulations.
SIVIEWConsole® is a Class I medical device accessory that complies with Regulation (EU) 2017/745 on medical devices. SIVIEWConsole® is a software accessory used as a universal manual control tool that allows for the manual operation of instruments connected to SIVIEWBox®. Use of the device is restricted to healthcare professionals authorized to perform eye exams or to delegate such exams. This medical device is not covered by health insurance plans. Please read the provided user manuals carefully before use.
This medical device is a regulated health product that bears the CE mark in accordance with these regulations.
