LMA · Class II · 21 CFR 892.2030

FDA Product Code LMA: Digitizer, Image, Radiological

Leading manufacturers include Vidar Systems Corp., Lumisys, Inc. and Howtek, Inc..

61
Total
61
Cleared
115d
Avg days
1985
Since

FDA 510(k) Cleared Digitizer, Image, Radiological Devices (Product Code LMA)

61 devices
1–24 of 61
Cleared Oct 03, 2013
DICOM VIDEO
K132183
Bar Code Computer, Ltd.
Radiology · 80d
Cleared Jun 07, 2013
TELERADPRO EDGE
K130636
Vidar Systems Corp.
Radiology · 88d
Cleared Apr 29, 2013
DIAGNOSTICPRO EDGE
K130406
Vidar Systems Corp.
Radiology · 69d
Cleared Oct 07, 2010
TELERADPRO
K102476
Vidar Systems Corp.
Radiology · 38d
Cleared Jan 07, 2010
VIDAR DENTAL FILM DIGITIZER
K093809
Vidar Systems Corp.
Radiology · 29d
Cleared Aug 14, 2009
MEDI-6000 MEDICAL IMAGE DIGITIZER
K091288
Microtek International, Inc.
Radiology · 105d
Cleared Dec 21, 2006
FILM DIGITZER, MODEL 2908 MAMMO PRO
K063424
Array Corp.
Radiology · 38d
Cleared Oct 20, 2004
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484
Nai Technology Products
Radiology · 37d
Cleared Dec 17, 2003
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637
Array Corp.
Radiology · 28d
Cleared Sep 02, 2003
DIGITAL IMAGER
K032022
Pyramid Medical, Inc.
Radiology · 64d
Cleared Oct 11, 2002
COBRASCAN CR-1 FILMLESS
K022810
Radiographic Digital Imaging, Inc.
Radiology · 49d
Cleared Aug 12, 2002
FULCRUM
K021949
Howtek, Inc.
Radiology · 60d
Cleared Mar 05, 2002
LASERPRO 16
K020243
Eradlink, Inc.
Radiology · 41d
Cleared Nov 20, 2001
EFILM VIDEO
K013631
Efilm Medical, Inc.
Radiology · 15d
Cleared Oct 30, 2001
LIFEJET VIDEO LINK
K013395
Ferrania S.P.A.
Radiology · 15d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049
Vidar Systems Corp.
Radiology · 178d
Cleared Nov 15, 2000
35/CD CINECONVERTER
K001841
Tagarno A/S
Radiology · 149d
Cleared Apr 14, 2000
CHILI VIDEO, CHILI VIDEOPRO
K000411
Steinbeis-Transferzentrum Medizinische Informatik
Radiology · 66d
Cleared Feb 10, 2000
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K992467
Dba Systems, Inc.
Radiology · 202d
Cleared Jan 20, 2000
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K993598
Vidar Systems Corp.
Radiology · 87d
Cleared Jan 18, 2000
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
K993599
Vidar Systems Corp.
Radiology · 85d
Cleared Dec 15, 1999
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597
Vidar Systems Corp.
Radiology · 51d
Cleared Mar 17, 1999
CCD CAMERA, MODEL 9000
K990066
Camtronics, Ltd.
Radiology · 68d
Cleared Feb 12, 1999
ELK LASER FILM DIGITIZER
K984409
Nishimoto Sangyo Co., Ltd.
Radiology · 65d

About Product Code LMA - Regulatory Context