Medical Device Manufacturer · US , New York , NY

Paieon, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2004
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paieon, Inc. Radiology ✕
8 devices
1-8 of 8
Cleared Dec 10, 2012
CARDNAV
K120282 · OWB
Radiology · 314d
Cleared Mar 02, 2012
C-THV SYSTEM
K113594 · IZI
Radiology · 88d
Cleared May 27, 2011
THE IC-PRO SYSTEM
K110256 · IZI
Radiology · 119d
Cleared Feb 17, 2009
THE IC-PRO SYSTEM, MODEL VERSION 3.2
K083745 · IZI
Radiology · 63d
Cleared Nov 18, 2008
IC-PRO SYSTEM, VERSION 3.1.0.4
K082907 · IZI
Radiology · 49d
Cleared Sep 09, 2008
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
K073328 · IZI
Radiology · 287d
Cleared Oct 10, 2007
CARDIOP-B SYSTEM, VERSION 2.1
K072591 · IZI
Radiology · 26d
Cleared Apr 02, 2004
THE CARDIOP-B SYSTEM
K030139 · IZI
Radiology · 444d
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