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 K110573
Device Name READY VIEW
Applicant
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
3200 N GRANDVIEW BLVD,
W-827
waukesha,  WI  53188
Applicant Contact elizabeth mathew
Correspondent
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
3200 N GRANDVIEW BLVD,
W-827
waukesha,  WI  53188
Correspondent Contact elizabeth mathew
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/01/2011
Decision Date 05/03/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-