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 K120636
Device Name SYNAPSE 3D CARDIAC TOOLS
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact JYH-SHYAN LIN
Correspondent
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact JYH-SHYAN LIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/01/2012
Decision Date 07/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-