Invivo Corporation - FDA 510(k) Cleared Devices
Recent clearances: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T, Philips MR Patient Care Portal, DynaCAD
29
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Invivo Corporation Radiology ✕
19 devices
Cleared
Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
Radiology
22d
Cleared
Aug 02, 2021
DynaCAD
Radiology
21d
Cleared
Dec 27, 2019
UroNav System
Radiology
21d
Cleared
Oct 09, 2019
DynaCAD
Radiology
57d
Cleared
Oct 19, 2018
UroNav (Version 3.0)
Radiology
31d
Cleared
Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
Radiology
41d
Cleared
Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
Radiology
42d
Cleared
Nov 16, 2015
UroNav (Version 2.0)
Radiology
25d
Cleared
Jan 22, 2014
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
Radiology
118d
Cleared
Dec 21, 2012
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
Radiology
91d
Cleared
Nov 02, 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
Radiology
64d
Cleared
Feb 10, 2012
SENSE MSK S 8CH 1.5T
Radiology
24d
Cleared
Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
Radiology
191d
Cleared
Jan 03, 2011
1.5T 16-CHANNEL HAND-WRIST COIL
Radiology
70d
Cleared
Mar 05, 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
Radiology
80d
Cleared
Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
Radiology
104d
Cleared
Jun 17, 2008
DC NEURO
Radiology
43d
Cleared
Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
Radiology
28d
Cleared
Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
Radiology
21d