LMB · Class I · 21 CFR 892.2010

FDA Product Code LMB: Device, Digital Image Storage, Radiological

Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.

Leading manufacturers include Eastman Kodak Company, Eigen and Camtronics, Ltd..

55
Total
55
Cleared
120d
Avg days
1983
Since
55 devices
49–55 of 55
Cleared Jun 28, 1988
HR-1000 W/SUFFIXES (B,C OR D)
K882184
Eigen
Radiology · 35d
Cleared Oct 30, 1987
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
K873048
Eastman Kodak Company
Radiology · 87d
Cleared Oct 27, 1986
ADVANCED NUCLEAR COMPUTER
K862842
Advanced Nuclear Imaging Corp.
Radiology · 90d
Cleared Oct 27, 1986
ERS SYSTEM
K863286
General Electric Co.
Radiology · 63d
Cleared Jan 22, 1985
MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER
K844132
Sigma Teleproducts, Inc.
Radiology · 91d
Cleared Dec 17, 1984
ND3100 VIDEO IMAGER
K843349
Nuclear Data, Inc.
Radiology · 112d
Cleared Nov 21, 1983
CEMAX-1000
K833525
Contour Medical Systems, Inc.
Radiology · 60d