FDA 510(k) Applications Submitted by Debbie Peacock
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120361 |
02/06/2012 |
SYNAPSE 3D BASE TOOLS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
| K100762 |
03/17/2010 |
FLAT PANEL DETECTOR, MODEL FDR D-EVO |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K070920 |
04/02/2007 |
FUJI IP CASSETTE TYPE PC |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K080945 |
04/03/2008 |
FCR GO PORTABLE DIGITAL X-RAY SYSTEM |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K021120 |
04/08/2002 |
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP |
ARROW INTL., INC. |
| K161575 |
06/07/2016 |
Affirm Lateral Arm Upright Biopsy Accessory |
HOLOGIC |
| K111646 |
06/13/2011 |
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K061672 |
06/14/2006 |
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
| K101662 |
06/14/2010 |
SYNAPSE 3D BASIC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K101686 |
06/16/2010 |
FDR IMAGE STITCHING OPTION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K111865 |
06/30/2011 |
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K122454 |
08/13/2012 |
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K042793 |
10/07/2004 |
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K033335 |
10/16/2003 |
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K143088 |
10/28/2014 |
GastriSail Gastric Positioning System |
COVIDIEN |
| K093427 |
11/03/2009 |
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K043086 |
11/08/2004 |
SOMATOM RESPIRATORY GATING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K043087 |
11/08/2004 |
SOMATOM CARE CONTRAST CT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K103465 |
11/24/2010 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| K103687 |
12/17/2010 |
SYNAPSE 3D CEREBRAL ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
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