• 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 K023768
Device Name ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16
Applicant
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Applicant Contact WILLIAM SKREMSKY
Correspondent
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Correspondent Contact WILLIAM SKREMSKY
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/12/2002
Decision Date 11/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-