FDA 510(k) Applications Submitted by KONICA MINOLTA MEDICAL & GRAPHIC, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110717 |
03/15/2011 |
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K061999 |
07/14/2006 |
DRY LASER IMAGER, DRYPRO MODEL 832 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K013054 |
09/11/2001 |
KONICA DIRECT DIGITIZER REGIUS MODEL 350 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K023061 |
09/16/2002 |
KONICA DIRECT DIGITIZER REGIUS, MODEL 170 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K013052 |
09/11/2001 |
KONICA LASER IMAGER, DRYPRO MODEL 751/752 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K051998 |
07/25/2005 |
REGIUS MODEL 170 DIRECT DIGITIZER |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K052095 |
07/25/2005 |
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K120477 |
02/16/2012 |
AEROSYNC FOR AERODR SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K120752 |
03/12/2012 |
AERODR STITCHING SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K130936 |
04/04/2013 |
AERODR SYSTEM WITH P-31 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K071181 |
04/30/2007 |
DIRECT DIGITIZER, REGIUS MODEL 110 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K092717 |
09/03/2009 |
DIRECT DIGITIZER, REGIUS MODEL 210 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K120131 |
01/17/2012 |
REGIUS SIGMA2 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K071436 |
05/23/2007 |
REGIUS UNITEA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K081637 |
06/11/2008 |
LASER IMAGER DRYPRO MODEL 873 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K101842 |
07/01/2010 |
ACIES |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K102349 |
08/19/2010 |
AERODR SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K113248 |
11/03/2011 |
AERODR SYSTEM WITH P-21 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K123499 |
11/13/2012 |
AEROPILOT |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K103703 |
12/20/2010 |
REGUIS SIGMA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K121109 |
04/12/2012 |
AERODR X70 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K051418 |
06/01/2005 |
DIRECT DIGITIZER REGIUS MODEL 370 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K051521 |
06/08/2005 |
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K051523 |
06/08/2005 |
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K042133 |
08/09/2004 |
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K042386 |
09/02/2004 |
DIRECT DIGITIZER, REGIUS MODEL 190 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
| K053173 |
11/14/2005 |
DS CASSETTE |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
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