FDA 510(k) Applications Submitted by JOHN A DELUCIA

FDA 510(k) Number Submission Date Device Name Applicant
K180125 01/16/2018 PowerLook Density Assessment Software iCAD, Inc
K030960 03/27/2003 ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE ACMI CORPORATION
K141343 05/21/2014 AXXENT CERVICAL APPLICATOR ICAD, INC.
K011876 06/15/2001 DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 CIRCON VIDEO
K182373 08/31/2018 PowerLook Tomo Detection V2 Software iCAD Inc.
K153570 12/14/2015 Axxent Electronic Brachytherapy System Model 110 XP 1200 ICAD INC.
K090223 01/30/2009 ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 ICAD, INC.
K021166 04/11/2002 ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR ACMI-CIRCON CORPORATION
K091529 05/22/2009 ICAD VERALOOK CTC CAD SOFTWARE ICAD, INC.
K022480 07/26/2002 ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC ACMI CORPORATION
K122951 09/25/2012 XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 ICAD, INC.
K123442 11/08/2012 XOFT AXXENT CERVICAL APPLICATORS ICAD, INC.
K994328 12/22/1999 SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX GENZYME CORP.


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