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 K120851
Device Name COMMUNIFY PACS VIEWER
Applicant
Communify Health, LLC
160w 71st
18 Floor
New York,  NY  10023
Applicant Contact CHRIS RELYEA
Correspondent
Communify Health, LLC
160w 71st
18 Floor
New York,  NY  10023
Correspondent Contact CHRIS RELYEA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/21/2012
Decision Date 02/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-