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, Tomography, Computed, Emission
510(k) Number K211846
Device Name Discovery MI Gen2
Applicant
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Laura Turner
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Laura Turner
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/15/2021
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-