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 K230807
Device Name Deep Learning Image Reconstruction
Applicant
GE Healthcare Japan Corporation
7-127, 4-chome, Asahigaoka
Hino,  JP 191-8503
Applicant Contact He Haibo
Correspondent
GE Healthcare Japan Corporation
7-127, 4-chome, Asahigaoka
Hino,  JP 191-8503
Correspondent Contact He Haibo
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/23/2023
Decision Date 04/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-