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 System, Digital Image Communications, Radiological
510(k) Number K981053
Device Name KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
Applicant
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252 -8026
Applicant Contact ROBERT WOLFARTH
Correspondent
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252 -8026
Correspondent Contact ROBERT WOLFARTH
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/23/1998
Decision Date 06/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-