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, X-Ray, Tomography, Computed
510(k) Number K203617
Device Name MaxFOV 2
Applicant
GE Medical Systems, LLC.
3000 N Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Amy Yang
Correspondent
GE Medical Systems, LLC.
3000 N Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Amy Yang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/11/2020
Decision Date 03/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-