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, Digital Image Communications, Radiological
510(k) Number K965161
Device Name SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
Applicant
Sectra-Imtec AB
6741 Grant Ln.
Plano,  TX  75024
Applicant Contact HERMAN OOSTERWIJK
Correspondent
Sectra-Imtec AB
6741 Grant Ln.
Plano,  TX  75024
Correspondent Contact HERMAN OOSTERWIJK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received12/23/1996
Decision Date 03/12/1997
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
-
-