FDA 510(k) Applications for Medical Device Product Code "LMC"
(Camera, Multi Format, Radiological)

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


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