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, Image Processing, Radiological
510(k) Number K063188
Device Name DEL-IMS
Applicant
Del Medical Imaging Corp.
11550 W. King St.
Franklin Park,  IL  60131
Applicant Contact WILLIAM J ENGEL
Correspondent
Del Medical Imaging Corp.
11550 W. King St.
Franklin Park,  IL  60131
Correspondent Contact WILLIAM J ENGEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/20/2006
Decision Date 11/30/2006
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
-
-