Medical Device Manufacturer · DE , Darmstadt, Hessen

Medcom GmbH - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2002

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medcom GmbH Radiology ✕

11 devices

1-11 of 11

Cleared Sep 21, 2018

Radiology · 78d

Cleared Mar 27, 2018

Radiology · 53d

Cleared Jul 26, 2017

BiopSee, Mobile US

Radiology · 127d

Cleared May 01, 2017

NaviSuite SSI Edition

Radiology · 174d

Cleared Apr 03, 2014

VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE

Radiology · 101d

Cleared Nov 23, 2010

Radiology · 106d

Cleared May 07, 2010

MEDCOM RT-VIEWER SYSTEM

Radiology · 119d

Cleared Sep 18, 2009

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8

Radiology · 21d

Cleared May 09, 2008

VERISUITE 1.6, VERISUITE-PARTICLE 1.6

Radiology · 53d

Cleared Sep 25, 2003

EXOMIO, MODEL 2.0 SP1

Radiology · 38d

Cleared Oct 07, 2002

EXOMIO, MODEL 1.1

Radiology · 90d