INDICATIONS FOR USE AND REGULATORY STATUS
Product: Synapse® Mobility 8.0.0
UDI: (01)00854904006053(10)0800000
Year of Software Release:2020
Indications for use
The Synapse® Mobility solution is an enterprise medical image viewer used with off-the-shelf servers, web
browsers, and specific mobile devices for the 2D display, multi-planar reformatting and 3D visualization of
medical image data and reports. It provides collaboration and integrated secure audio-video
communication, and displays DICOM and non-DICOM medical images and reports.
The software is intended for use as a diagnostic, review, and analysis tool by trained healthcare
professionals to drive clinical management. When interpreted by a trained physician, reviewed images may
be used to aid in diagnosis. When used on a mobile device, Synapse Mobility is not intended to replace full
radiology workstations.
This product is not to be used for primary mammography diagnoses.
Regulatory status
Canada
The Synapse® Mobility software holds an active Class 2 license with Health Canada, the Canadian
ministry of health.
Canadian Distributor
Christie InnoMed Inc.
516 rue Dufour
St-Eustache, Quebec, Canada J7R 0C3
+1.800.361.8750 (phone)
+1.450.472.0413 (fax)
www.christieinnomed.com
European Community - Authorized Representative
CEpartner4U
Esdoornlaan 13
3951DB Maarn
The Netherlands
www.cepartner4u.com
2797
United States
Rx Only
Caution: Federal law restricts this device to sale by or on the order of a physician.
Synapse® Mobility User Guide for HTML5 Preface
Confidential and Proprietary
DOC-0046692-A
8
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