• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K122173
Device Name DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
Original Applicant
RAYENCE CO., LTD
12946 kimberley ln
houston,  TX  77079
Original Contact dave kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/23/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-