• 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 | Inspections

New Search Back To Search Results
Device Classification Name system, image processing, radiological
510(k) Number K121466
Device Name GUIDEMIA
Original Applicant
4841 ashbury ave.
cypress,  CA  90630
Original Contact fei gao
Regulation Number892.2050
Classification Product Code
Date Received05/17/2012
Decision Date 05/31/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No