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, image processing, radiological
510(k) Number K051315
Device Name MODIFICATION TO: SECTRA IDS5 WORKSTATION
Applicant
SECTRA IMTEC AB
1600 MANCHESTER WAY
CORINTH,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
SECTRA IMTEC AB
1600 MANCHESTER WAY
CORINTH,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/20/2005
Decision Date 06/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-