• 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 K023100
Device Name ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee,  WI  53223
Original Contact lisa lee michels
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/18/2002
Decision Date 10/11/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-