Page 56 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers
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Table C-1. Available U.S. FDA clearance status for noninvasive skin cancer diagnostic devices
               (continued)
                Device name    Company (country)      FDA clearance status         Intended use
                               Web site
                ULTRASOUND/LASER DOPPLER
                Cortex         Cortex Technology APS   • Approved by the FDA       To visualize layers of
                Dermascan C    (Denmark)              • 510(K983945)               the skin, including
                Ultrasonic     www.cortex.dk/         • FDA decision date: 03/17/1999   blood vessels
                System
                DUB 20         G.W.B. INTL., LTD. (USA)   • Approved by the FDA as Class   No data available
                                                        II device
                                                      • 510(K896029)
                                                      • FDA decision date: 01/12/1990
                SSA-340 A      Toshiba America Medical   • Approved by the FDA as Class   To accentuate minute
                (Modification)   System, Inc. (USA)     II device                  vascular structures
                               www.medical.toshiba.com   • 510(K960602)            and signal presence
                                                      • FDA decision date: 03/21/1996   of blood
                Sonoline       Siemens Medical        • Approved by the FDA as a   For peripheral
                Elegra         Solutions USA, Inc.(USA)   Class II device          vascular applications,
                Diagnostic                            • 510(K003125)               not specified
                Ultrasound                            • FDA decision date: 10/20/2000
                System
                MULTISPECTRAL IMAGING AND FULLY AUTOMATED COMPUTER-BASED ANALYSIS
                MelaFind       Electro-Optical Sciences,   • Unproven procedure
                               Inc. (USA)             • Filed a pre-market approval
                               www.eosciences.com       application in June 2009
                                                      • FDA advisory panel meeting
                                                        (Nov. 18, 2010): voted 8-7, a
                                                        recommendation for approval
                                                        of MelaFind as a skin cancer
                                                        detection device








































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