• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K120721
Device Name EOS
Original Applicant
EOS IMAGING
555 thirteenth street, nw
washington,  DC  20004
Original Contact john j smith
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/08/2012
Decision Date 04/06/2012
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
-
-