Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K060137
Device Name KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact LINDA STEWART
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact LINDA STEWART
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/19/2006
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-