Digitizer, Image, Radiological
Regulation 892.2030
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in LMA
| Company | 510(k)s | Recalls |
|---|---|---|
| Vidar Systems Corp. | 10 | 0 |
| Lumisys, Inc. | 5 | 0 |
| Array Corp. | 3 | 0 |
| Eastman Kodak Company | 3 | 0 |
| Howtek, Inc. | 3 | 0 |
| Dba Systems, Inc. | 2 | 0 |
| General Scanning, Inc. | 2 | 0 |
| Konica Medical Corp. | 2 | 0 |
| Radiographic Digital Imaging, Inc. | 2 | 0 |
| Adaptive Video, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2013 | K132183 | DICOM VIDEO Bar Code Computer, Ltd., IL | LMA |
| Jun 7, 2013 | K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD Vidar Systems Corp. | LMA |
| Apr 29, 2013 | K130406 | DIAGNOSTICPRO EDGE Vidar Systems Corp. | LMA |
| Oct 7, 2010 | K102476 | TELERADPRO Vidar Systems Corp. | LMA |
| Jan 7, 2010 | K093809 | VIDAR DENTAL FILM DIGITIZER Vidar Systems Corp. | LMA |
| Aug 14, 2009 | K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER Microtek International, Inc., TW | LMA |
| Dec 21, 2006 | K063424 | FILM DIGITZER, MODEL 2908 MAMMO PRO Array Corp., JP | LMA |
| Oct 20, 2004 | K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER Nai Technology Products | LMA |
| Dec 17, 2003 | K033637 | MEDICAL IMAGE DIGITIZER, MODEL 2908 Array Corp., JP | LMA |
| Sep 2, 2003 | K032022 | DIGITAL IMAGER Pyramid Medical, Inc. | LMA |
| Oct 11, 2002 | K022810 | COBRASCAN CR-1 FILMLESS Radiographic Digital Imaging, Inc. | LMA |
| Aug 12, 2002 | K021949 | FULCRUM Howtek, Inc. | LMA |
| Mar 5, 2002 | K020243 | LASERPRO 16 Eradlink, Inc. | LMA |
| Nov 20, 2001 | K013631 | EFILM VIDEO Efilm Medical, Inc., CA | LMA |
| Oct 30, 2001 | K013395 | LIFEJET VIDEO LINK Ferrania S.P.A., IT | LMA |
| Oct 1, 2001 | K011049 | EXPRESSSUITE Vidar Systems Corp. | LMA |
| Nov 15, 2000 | K001841 | 35/CD CINECONVERTER Tagarno A/S, DK | LMA |
| Apr 14, 2000 | K000411 | CHILI VIDEO, CHILI VIDEOPRO Steinbeis-Transferzentrum Medizinische Informatik | LMA |
| Feb 10, 2000 | K992467 | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM Dba Systems, Inc. | LMA |
| Jan 20, 2000 | K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 Vidar Systems Corp. | LMA |
| Jan 18, 2000 | K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 Vidar Systems Corp. | LMA |
| Dec 15, 1999 | K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 Vidar Systems Corp. | LMA |
| Mar 17, 1999 | K990066 | CCD CAMERA, MODEL 9000 Camtronics, Ltd. | LMA |
| Feb 12, 1999 | K984409 | ELK LASER FILM DIGITIZER Nishimoto Sangyo Co., Ltd. | LMA |
| Jan 25, 1999 | K984252 | IMATION TRIMATIC DIGITAL SYSTEM Imation Corp. | LMA |
| Oct 15, 1998 | K982785 | FILM DIGITIZER MODEL 2905 Array Corp., JP | LMA |
| Jun 19, 1998 | K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 Konica Corp. | LMA |
| May 11, 1998 | K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER Lumisys, Inc. | LMA |
| Apr 17, 1998 | K974315 | VIDAR VXR LS LASER FILM DIGITIZER Vidar Systems Corp. | LMA |
| Mar 19, 1998 | K980565 | LD2000 SERIES General Scanning, Inc. | LMA |
| Mar 17, 1998 | K980213 | DI-2000 Lumisys, Inc. | LMA |
| Feb 25, 1998 | K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM Afp Imaging Corp. | LMA |
| Dec 4, 1997 | K973411 | DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) General Scanning, Inc. | LMA |
| Aug 20, 1997 | K971894 | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM Eastman Kodak Company | LMA |
| May 20, 1997 | K970908 | HOWTEK 960 Howtek, Inc. | LMA |
| Apr 23, 1997 | K964288 | CALL-RAD PC TELERADIOLOGY Pc Teleradiology | LMA |
| Dec 18, 1996 | K960839 | FILM SCANNER 300 Cannon U.S.A., Inc. | LMA |
| Aug 22, 1996 | K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) Kodak Health Imaging Systems, Inc. | LMA |
| Jan 18, 1996 | K953117 | SCANMASTER DX Howtek, Inc. | LMA |
| Jan 2, 1996 | K954875 | ASPECT ACQUISITION MODULE (AAM) Aspect Electronics, Inc. | LMA |
| Dec 22, 1995 | K953942 | COBRASCAN CX-312 Radiographic Digital Imaging, Inc. | LMA |
| Nov 24, 1995 | K952485 | LASERNET IMAGE MANAGER/PRINT SERVER Frantz Imaging, Inc. | LMA |
| Sep 18, 1995 | K953964 | LUMISYS, LUMISCAN 20 Lumisys, Inc. | LMA |
| Nov 22, 1994 | K943357 | CEMAX SCANLINK V Cemax, Inc. | LMA |
| Oct 20, 1994 | K932760 | DFS-2100 Dba Systems, Inc. | LMA |
| Feb 18, 1994 | K925799 | AD/V A.5 Adaptive Video, Inc. | LMA |
| Dec 14, 1993 | K933830 | KONICA LD-4500 LASER DIGITIZER Konica Medical Corp. | LMA |
| Dec 13, 1993 | K933632 | MEDSCAN 12 Vidar Systems Corp. | LMA |
| Oct 7, 1993 | K933129 | LUMISCAN 50 Lumisys, Inc. | LMA |
| Feb 26, 1993 | K925721 | KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE Eastman Kodak Company | LMA |
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