• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name system, image processing, radiological
510(k) Number K072986
Device Name INTEGRADWEB PACS SYSTEM
Original Applicant
GE HEALTHCARE
25 walnut street
monroe,  CT  06468
Original Contact jillian m reed
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/23/2007
Decision Date 11/20/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
-
-