FDA 510(k) Applications for Medical Device Product Code "LMA"
(Digitizer, Image, Radiological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K974619 | AFP IMAGING CORP. | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | 02/25/1998 |
| K982785 | ARRAY CORP. | FILM DIGITIZER MODEL 2905 | 10/15/1998 |
| K063424 | ARRAY CORP. | FILM DIGITZER, MODEL 2908 MAMMO PRO | 12/21/2006 |
| K033637 | ARRAY CORP. | MEDICAL IMAGE DIGITIZER, MODEL 2908 | 12/17/2003 |
| K954875 | ASPECT ELECTRONICS, INC. | ASPECT ACQUISITION MODULE (AAM) | 01/02/1996 |
| K132183 | BAR CODE COMPUTER LTD | DICOM VIDEO | 10/03/2013 |
| K990066 | CAMTRONICS, LTD. | CCD CAMERA, MODEL 9000 | 03/17/1999 |
| K960839 | CANNON U.S.A., INC. | FILM SCANNER 300 | 12/18/1996 |
| K992467 | DBA SYSTEMS, INC. | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | 02/10/2000 |
| K971894 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM | 08/20/1997 |
| K013631 | EFILM MEDICAL, INC. | EFILM VIDEO | 11/20/2001 |
| K020243 | ERADLINK, INC. | LASERPRO 16 | 03/05/2002 |
| K013395 | FERRANIA S.P.A. | LIFEJET VIDEO LINK | 10/30/2001 |
| K973411 | GENERAL SCANNING, INC. | DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) | 12/04/1997 |
| K980565 | GENERAL SCANNING, INC. | LD2000 SERIES | 03/19/1998 |
| K021949 | HOWTEK, INC. | FULCRUM | 08/12/2002 |
| K970908 | HOWTEK, INC. | HOWTEK 960 | 05/20/1997 |
| K953117 | HOWTEK, INC. | SCANMASTER DX | 01/18/1996 |
| K984252 | IMATION CORP. | IMATION TRIMATIC DIGITAL SYSTEM | 01/25/1999 |
| K961768 | KODAK HEALTH IMAGING SYSTEMS, INC. | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) | 08/22/1996 |
| K980873 | KONICA CORP. | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | 06/19/1998 |
| K980213 | LUMISYS, INC. | DI-2000 | 03/17/1998 |
| K980809 | LUMISYS, INC. | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | 05/11/1998 |
| K091288 | MICROTEK INTERNATIONAL, INC. | MEDI-6000 MEDICAL IMAGE DIGITIZER | 08/14/2009 |
| K042484 | NAI TECHNOLOGY PRODUCTS | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | 10/20/2004 |
| K984409 | NISHIMOTO SANGYO CO., LTD. | ELK LASER FILM DIGITIZER | 02/12/1999 |
| K964288 | PC TELERADIOLOGY | CALL-RAD PC TELERADIOLOGY | 04/23/1997 |
| K032022 | PYRAMID MEDICAL, INC. | DIGITAL IMAGER | 09/02/2003 |
| K022810 | RADIOGRAPHIC DIGITAL IMAGING, INC. | COBRASCAN CR-1 FILMLESS | 10/11/2002 |
| K000411 | STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK | CHILI VIDEO, CHILI VIDEOPRO | 04/14/2000 |
| K001841 | TAGARNO A/S | 35/CD CINECONVERTER | 11/15/2000 |
| K993599 | VIDAR SYSTEMS CORP. | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | 01/18/2000 |
| K130406 | VIDAR SYSTEMS CORP. | DIAGNOSTICPRO EDGE | 04/29/2013 |
| K011049 | VIDAR SYSTEMS CORP. | EXPRESSSUITE | 10/01/2001 |
| K993598 | VIDAR SYSTEMS CORP. | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | 01/20/2000 |
| K993597 | VIDAR SYSTEMS CORP. | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 | 12/15/1999 |
| K102476 | VIDAR SYSTEMS CORP. | TELERADPRO | 10/07/2010 |
| K130636 | VIDAR SYSTEMS CORP. | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | 06/07/2013 |
| K093809 | VIDAR SYSTEMS CORP. | VIDAR DENTAL FILM DIGITIZER | 01/07/2010 |
| K974315 | VIDAR SYSTEMS CORP. | VIDAR VXR LS LASER FILM DIGITIZER | 04/17/1998 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
