FDA 510(k) Applications Submitted by Carolyn L. Wagner

FDA 510(k) Number Submission Date Device Name Applicant
K120062 01/09/2012 DRX-REVOLUTION MOBILE X-RAY SYSTEM CARESTREAM HEALTH, INC.
K900206 01/16/1990 LYME DISEASE IGM ELISA HILLCREST BIOLOGICALS
K130464 02/22/2013 CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR CARESTREAM HEALTH,INC.
K130567 03/04/2013 DR LONG LENGTH IMAGING SOFTWARE CARESTREAM HEALTH, INC.
K160723 03/16/2016 OnSight 3D Extremity System CARESTREAM HEALTH, INC.
K922374 05/20/1992 Q FEVER IGM IFA TEST HILLCREST BIOLOGICALS
K091889 06/24/2009 DRX-EVOLUTION, MODEL VX3733-SYS CARESTREAM HEALTH, INC.
K913617 08/13/1991 ARBOVIRUS IGG IFA TEST HILLCREST BIOLOGICALS
K913618 08/13/1991 ARBOVIRUS IGM IFA TEST HILLCREST BIOLOGICALS
K913906 08/30/1991 Q FEVER IGG IFA TEST HILLCREST BIOLOGICALS
K133442 11/12/2013 BONE SUPPRESSION SOFTWARE CARESTREAM HEALTH, INC.
K884591 11/03/1988 EBV-VCA ANTIBODY (IGG) HILLCREST BIOLOGICALS
K884829 11/18/1988 EBV EARLY ANTIGEN (R+D) HILLCREST BIOLOGICALS
K896594 11/21/1989 EBV VCA ANTIBODY (IGM) HILLCREST BIOLOGICALS
K060055 01/09/2006 KODAK PACS EASTMAN KODAK COMPANY
K150342 02/11/2015 Touch Ultrasound CARESTREAM HEALTH, INC.
K150766 03/24/2015 Carestream DRX-1 System Carestream Health, Inc.
K151774 07/01/2015 CARESTREAM Vue Motion CARESTREAM HEALTH, INC.
K141837 07/07/2014 DRX-EVOLUTION CARESTREAM HEALTH,INC.
K053347 12/02/2005 KODAK CARESTREAM PACS EASTMAN KODAK COMPANY
K152467 08/31/2015 Touch Ultrasound CARESTREAM HEALTH, INC.
K163203 11/15/2016 Carestream DRX-Evolution Carestream Health, Inc.


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