Medical Device Manufacturer · FR , La Tronche

Koelis - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2010

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Koelis Radiology ✕

7 devices

1-7 of 7

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

Radiology · 84d

Cleared Jul 11, 2014

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