Eastman Kodak Company

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
238
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386March 31, 2006
K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREMarch 16, 2006
K060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMFebruary 8, 2006
K060055KODAK PACSFebruary 7, 2006
K053347KODAK CARESTREAM PACSJanuary 4, 2006
K051483KODAK DIRECTVIEW DR SYSTEM DETECTORJune 21, 2005
K051258KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345June 1, 2005
K042159KODAK COLOR MEDICAL IMAGER 1000September 24, 2004
K042158KODAK MEDICAL IMAGER 300September 24, 2004
K040378KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253May 24, 2004
K040556TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORYApril 7, 2004
K033821KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORYFebruary 20, 2004
K031132CONSULTIVA CASE INPUT STATION, MODEL CIS-1November 26, 2003
K030781KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CXMay 29, 2003
K021903KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USEJuly 10, 2002
K021829MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEMJuly 2, 2002
K020635KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976March 21, 2002
K013686KODAK DIRECTVIEW TABLETOP CASSETTEDecember 7, 2001
K012155KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMSAugust 10, 2001
K002146KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHYSeptember 27, 2000