Koelis - FDA 510(k) Cleared Devices
Recent clearances: Disposable guides KDNG00, Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range, TRINITY/3D PROSTATE SUITE
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Koelis Radiology ✕
7 devices
Cleared
Jul 10, 2018
Disposable guides KDNG00
Radiology
88d
Cleared
Jul 31, 2017
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD...
Radiology
116d
Cleared
May 30, 2017
TRINITY/3D PROSTATE SUITE
Radiology
97d
Cleared
May 02, 2016
TRINITY
Radiology
84d
Cleared
Jul 11, 2014
REUSABLE GUIDE
Radiology
51d
Cleared
Jul 26, 2013
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND...
Radiology
67d
Cleared
Sep 22, 2010
UROSTATION 3D PROSTATE SUITE
Radiology
184d