LMA · Class II · 21 CFR 892.2030

FDA Product Code LMA: Digitizer, Image, Radiological

Leading manufacturers include Vidar Systems Corp., Eastman Kodak Company and General Scanning, 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 20, 2004
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484
Nai Technology Products
Radiology · 37d
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
Cleared Jan 25, 1999
IMATION TRIMATIC DIGITAL SYSTEM
K984252
Imation Corp.
Radiology · 59d
Cleared Oct 15, 1998
FILM DIGITIZER MODEL 2905
K982785
Array Corp.
Radiology · 69d
Cleared Jun 19, 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873
Konica Corp.
Radiology · 105d
Cleared May 11, 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809
Lumisys, Inc.
Radiology · 69d
Cleared Apr 17, 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315
Vidar Systems Corp.
Radiology · 151d
Cleared Mar 19, 1998
LD2000 SERIES
K980565
General Scanning, Inc.
Radiology · 34d
Cleared Mar 17, 1998
DI-2000
K980213
Lumisys, Inc.
Radiology · 67d
Cleared Feb 25, 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619
Afp Imaging Corp.
Radiology · 76d
Cleared Dec 04, 1997
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411
General Scanning, Inc.
Radiology · 86d
Cleared Aug 20, 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894
Eastman Kodak Company
Radiology · 90d
Cleared May 20, 1997
HOWTEK 960
K970908
Howtek, Inc.
Radiology · 70d
Cleared Apr 23, 1997
CALL-RAD PC TELERADIOLOGY
K964288
Pc Teleradiology
Radiology · 177d
Cleared Dec 18, 1996
FILM SCANNER 300
K960839
Cannon U.S.A., Inc.
Radiology · 296d
Cleared Aug 22, 1996
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768
Kodak Health Imaging Systems, Inc.
Radiology · 106d

About Product Code LMA - Regulatory Context