Page 56 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

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

C-2