FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K032635 |
AGFA CORP. |
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 |
09/24/2003 |
K023287 |
AGFA CORP. |
DRYSTAR 5500 |
10/22/2002 |
K012941 |
AGFA CORP. |
DRYSTAR, MODEL 4500M |
11/29/2001 |
K022658 |
AGFA CORP. |
LR DICOM CONTROLLER |
09/06/2002 |
K012010 |
AGFA CORP. |
MODIFICATION TO LR 5200 FILM RECORDER |
09/20/2001 |
K052251 |
AGFA CORPORATION |
DRYSTAR MODEL 5500 |
08/31/2005 |
K072680 |
AGFA HEALTHCARE CORPORATION |
DRYSTAR AXYS, MODEL EYZ4E |
10/25/2007 |
K010275 |
AGFA MEDICAL IMAGING |
DRYSTAR 4500 PRINTER, MODEL 4500 |
04/27/2001 |
K962051 |
ASPECT ELECTRONICS, INC. |
ASPECT OPTICAM |
08/23/1996 |
K964414 |
BAYER CORP., AGFA DIV. |
LR 5200 LASER FILM RECORDER |
01/27/1997 |
K090469 |
CARESTREAM HEALTH, INC. |
CARESTREAM DRYVIEW 5850 LASER IMAGER |
05/22/2009 |
K111566 |
CARESTREAM HEALTH,INC. |
DRYVIEW CHROMA IMAGING SYSTEM |
10/06/2011 |
K030690 |
CODONICS, INC. |
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS |
04/30/2003 |
K021054 |
CODONICS, INC. |
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER |
05/09/2002 |
K060440 |
CODONICS, INC. |
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER |
03/16/2006 |
K962364 |
CODONICS, INC. |
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) |
11/08/1996 |
K003481 |
CODONICS, INC. |
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 |
01/19/2001 |
K042232 |
CODONICS, INC. |
NP-2600 SERIES HARDCOPY PRINTERS |
10/05/2004 |
K973422 |
DEJARNETTE RESEARCH SYSTEMS |
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) |
10/28/1997 |
K042159 |
EASTMAN KODAK COMPANY |
KODAK COLOR MEDICAL IMAGER 1000 |
09/24/2004 |
K983905 |
EASTMAN KODAK COMPANY |
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 |
01/25/1999 |
K972847 |
EASTMAN KODAK COMPANY |
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) |
10/07/1997 |
K002146 |
EASTMAN KODAK COMPANY |
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY |
09/27/2000 |
K033821 |
EASTMAN KODAK COMPANY |
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY |
02/20/2004 |
K042158 |
EASTMAN KODAK COMPANY |
KODAK MEDICAL IMAGER 300 |
09/24/2004 |
K011617 |
FERRANIA S.P.A. STABILIMENTO DI FERRANIA |
LIFEJET PRINTER 400 |
06/08/2001 |
K962967 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FUJI MEDICAL DRY IMAGER FM-DP 2636 |
10/28/1996 |
K033377 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L |
01/09/2004 |
K972163 |
IMATION CORP. |
IMATION SE-196 LASER IMAGER |
09/05/1997 |
K972822 |
IMATION ENTERPRISES CORP. |
IMATION SE-204 LASER IMAGER |
11/19/1997 |
K953165 |
INTERNATIONAL IMAGING ELECTRONICS |
ULTRA COMPACT VIDEO IMAGER |
05/07/1996 |
K992586 |
KONICA CORP. |
KONICA LASER IMAGER, DRYPRO MODEL 722 |
10/29/1999 |
K032681 |
KONICA MEDICAL AND GRAPHIC CORPORATION |
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 |
09/24/2003 |
K061999 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
DRY LASER IMAGER, DRYPRO MODEL 832 |
08/15/2006 |
K042133 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 |
11/24/2004 |
K013052 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
KONICA LASER IMAGER, DRYPRO MODEL 751/752 |
01/16/2002 |
K081637 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
LASER IMAGER DRYPRO MODEL 873 |
07/01/2008 |
K061302 |
MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS |
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU |
06/23/2006 |
K011949 |
NISHIMOTO SANGYO CO., LTD. |
ELK LASER IMAGER, MODEL EL-DRY 4000 |
08/29/2001 |
K991282 |
SEIKO INSTRUMENTS USA, INC. |
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES |
06/30/1999 |
K971760 |
SEIKO INSTRUMENTS USA, INC. |
COLORPOINT OR PROFESSIONAL COLORPOINT |
10/01/1997 |
K955394 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIENET TELERADIOLOGY PRODUCT LINE |
02/21/1996 |
K141454 |
SONY ELECTRONICS, INC. |
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD |
06/26/2014 |
K141346 |
SONY ELECTRONICS, INC. |
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD |
06/26/2014 |
K083522 |
SONY ELECTRONICS, INC. |
SONY UP-DF750 DIGITAL FILM IMAGER |
01/09/2009 |
K024188 |
SONY MEDICAL SYSTEMS |
UP-DF500 FILMSTATION DIGITAL FILM IMAGER |
02/04/2003 |
K973028 |
STERLING DIAGNOSTIC IMAGING, INC. |
HELIOS LASER IMAGER 1417 |
10/28/1997 |
K972660 |
STERLING DIAGNOSTIC IMAGING, INC. |
RAVEN DRY PRINTER |
11/10/1997 |
K092280 |
VIRTUAL IMAGING, INC. |
CYPHER DICOM PRINT SOLUTION |
10/16/2009 |