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 K182750
Device Name 4D View
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics,
9900 W Innovation Drive
wauwatosa,  WI  53226
Applicant Contact tracey ortiz
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics,
9900 W Innovation Drive
wauwatosa,  WI  53226
Correspondent Contact tracey ortiz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2018
Decision Date 12/21/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-