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RemotEye Lite, version 2.2.4 Review web DICOM viewer |
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NeoLogica s.r.l. Strada Ville, 58 17014 - Cairo Montenotte (SV) Italy Contact NeoLogica at: info@neologica.it http://www.neologica.it |
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Software serial number <> |
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Please read the User Manual before use. |
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RemotEye Lite is part of the RemotEye Suite product. |
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According to the guidelines stated in Directive 93/42 of the European Community, as later modified by Directive 2007/47, RemotEye Lite is a Class I Medical Device. RemotEye Lite satisfies the requirements for bearing the CE mark on its labelling. |
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According to the FDA classification rules, RemotEye Lite is a "Medical Image Communication Device". As such, it is a Class I Medical Device. NeoLogica satisfies the requirements stated by the FDA for manufacturer of Class I devices, including Establishment Registration, Device Listing, U.S. Agent and Quality System (QS) regulation (21 CFR Part 820). |