Page 55 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers
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Appendix C. FDA Clearance and Clinical Trials Status


               Table C-1. Available U.S. FDA clearance status for noninvasive skin cancer diagnostic devices
                Device name    Company (country)      FDA clearance status         Intended use
                               Web site
                DERMOSCOPY
                EpiScope       Welch Allyn (USA)      • Approved by the FDA Class I   To illuminate body
                (MODEL         www.welchallyn.com       device                     surfaces and cavities
                47300)                                • 510(K920103)
                                                      • FDA decision date: 04/28/1992
                Nevoscope      TransLite (USA)        • Approved by the FDA as Class   To view skin lesions
                               www.tlite.com            I device                   by either surface
                                                      • 510(K954943)               illumination or
                                                      • FDA decision date: 03/27/1996   transillumination
                Dermascope     American Diagnostic    • Approved by the FDA as Class   To enlarge images
                               Corp. (USA)              I device in 1999           for medical purposes
                               www.adctoday.com
                MoleMax        Derma Medical Systems   • Approved by the FDA as Class   To enlarge images
                               www.dermamedicalsyste    I device in 1999           for medical purposes
                               ms.com
                MicroDerm      Visiomed AG (USA)      • Approved by the FDA as Class   To acquire and store
                               www.visiomedag.com       II device                  images of skin
                                                      • 510(K032760)               surfaces
                                                      • FDA decision date: 04/27/2004
                CONFOCAL MICROSCOPY
                VivaScope®     Lucid, Inc. (USA)      • Approved by the FDA as Class   To acquire, store,
                1500           www.lucid-tech.com       II device                  retrieve, display, and
                VivaScope®                            • 510(k) number: K080788     transfer in vivo
                2500                                  • FDA decision date: 09/05/2008   images of tissue
                VivaScope®
                3000
                Optiscan™      Optiscan Pty Ltd       • Approved by the FDA as Class   This device was
                               (Australia)              II device                  listed as a confocal
                               www.optiscan.com       • 510(k) number: K093624     microscopy device for
                                                      • FDA decision date: 02/19/2010   skin lesion evaluation
                                                                                   in a published
                                                                                         37
                                                                                   review.  However,
                                                                                   the intended use
                                                                                   listed in the FDA
                                                                                   summary is for the
                                                                                   imaging of the
                                                                                   internal
                                                                                   microstructure of
                                                                                   tissues during
                                                                                   endoscopic medical
                                                                                   procedures.



















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