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 K884667
Device Name EXEL 905 SERIES CT SCANNER
Applicant
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Applicant Contact SOBEL
Correspondent
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Correspondent Contact SOBEL
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/08/1988
Decision Date 12/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-