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
61 devices
25–48 of 61
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
Cleared Jan 18, 1996
SCANMASTER DX
K953117
Howtek, Inc.
Radiology · 199d
Cleared Jan 02, 1996
ASPECT ACQUISITION MODULE (AAM)
K954875
Aspect Electronics, Inc.
Radiology · 70d
Cleared Dec 22, 1995
COBRASCAN CX-312
K953942
Radiographic Digital Imaging, Inc.
Radiology · 141d
Cleared Nov 24, 1995
LASERNET IMAGE MANAGER/PRINT SERVER
K952485
Frantz Imaging, Inc.
Radiology · 178d
Cleared Sep 18, 1995
LUMISYS, LUMISCAN 20
K953964
Lumisys, Inc.
Radiology · 27d
Cleared Nov 22, 1994
CEMAX SCANLINK V
K943357
Cemax, Inc.
Radiology · 133d
Cleared Oct 20, 1994
DFS-2100
K932760
Dba Systems, Inc.
Radiology · 499d
Cleared Feb 18, 1994
AD/V A.5
K925799
Adaptive Video, Inc.
Radiology · 459d
Cleared Dec 14, 1993
KONICA LD-4500 LASER DIGITIZER
K933830
Konica Medical Corp.
Radiology · 131d
Cleared Dec 13, 1993
MEDSCAN 12
K933632
Vidar Systems Corp.
Radiology · 139d