Ziosoft, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ziosoft, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ziostation2, Ziostation2
6
Total
6
Cleared
0
Denied
Ziosoft, Inc. has 6 FDA 510(k) cleared medical devices. Based in Irvine, US.
Historical record: 6 cleared submissions from 2007 to 2020. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Ziosoft, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Ziosoft USA, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Ziosoft, Inc.
6 devices
Cleared
May 05, 2020
Ziostation2
Radiology
88d
Cleared
Oct 09, 2018
Ziostation2
Radiology
88d
Cleared
Jun 29, 2009
MR CARDIAC FUNCTION ANALYSIS
Radiology
61d
Cleared
Mar 31, 2009
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
Radiology
130d
Cleared
Dec 19, 2008
CT BRAIN PERFUSION FOR ZIOSTATION
Radiology
64d
Cleared
Mar 23, 2007
ZIOSTATION
Radiology
60d