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 K020913
Device Name CT-C3000 SPIRAL CT SCANNER SYSTEM
Applicant
Neusoft Digital Medical Systems Co., Ltd.
#3-11, Wenhua Rd.
Heping District
Shenyang, Liaoning,  CN 110004
Applicant Contact WANG ZHIQIANG
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact WOLFRAM GMELIN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/21/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-