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, X-Ray, Angiographic
510(k) Number K083745
Device Name THE IC-PRO SYSTEM, MODEL VERSION 3.2
Applicant
Paieon, Inc.
22 Hamelacha St., P.O.B. 11355
Rosh Haayin,  IL 48901
Applicant Contact SHAHAR MANDELBOIM
Correspondent
Paieon, Inc.
22 Hamelacha St., P.O.B. 11355
Rosh Haayin,  IL 48901
Correspondent Contact SHAHAR MANDELBOIM
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/16/2008
Decision Date 02/17/2009
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
-
-