• 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 transducer, ultrasonic, diagnostic
510(k) Number K121062
Device Name VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
GE MEDICAL SYSTEM ISRAEL LTD.
9900 innovation dr
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO   LLZ  
Date Received04/06/2012
Decision Date 08/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-