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, Tomography, Computed, Emission
510(k) Number K910048
Device Name ECAT SCANNER
Applicant
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
P.O. BOX 22999
KNOXVILLE,  TN  37932 -2562
Applicant Contact MARK S ANDREACO
Correspondent
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
P.O. BOX 22999
KNOXVILLE,  TN  37932 -2562
Correspondent Contact MARK S ANDREACO
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/07/1991
Decision Date 05/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-