• 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 K123596
Device Name OPTIMA CT520
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO. 2 N. YONGCHANG STREET
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA
BEIJING,  CN 100176
Applicant Contact HELEN PENG
Correspondent
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO. 2 N. YONGCHANG STREET
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA
BEIJING,  CN 100176
Correspondent Contact HELEN PENG
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/21/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-