# Medcom GmbH

- Location (FDA's records): Darmstadt, Hessen, DE
- FDA decisions: 11 (2002–2018): 11 510(k) clearances
- Product codes: LHN (3), LLZ (2), KPQ (2), MUJ (2), IYE (2)
- 510(k) review time since 2016: median 103 days, against 93 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 18 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainlab AG: 3 (https://510kreport.com/company/brainlab)
- Mimvista Corp.: 2 (https://510kreport.com/company/mimvista)
- Esaote, S.p.A.: 1 (https://510kreport.com/company/esaote)
- Varian Assoc., Inc.: 1 (https://510kreport.com/company/varian-assoc)
- Gmv Soluciones Globales Internet S.A.U.: 1 (https://510kreport.com/company/gmv-soluciones-globales-internet-sau)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Ralco S.R.L.: 1 (https://510kreport.com/company/ralco)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)

## Firms that cite its devices most
- Ion Beam Applications S.A.: 1 (https://510kreport.com/company/ion-beam-applications)
- Hitachi, Ltd. Healthcare: 1 (https://510kreport.com/company/hitachi-healthcare)

## Its most-cited devices
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle (2014), cited by 2
- K080742: Verisuite 1.6, Verisuite-Particle 1.6 (2008), cited by 2
- K092653: Verisuite and Verisuite-Particle, Version 1.8 (2009), cited by 2
- K163119: NaviSuite SSI Edition (2017), cited by 1
- K022219: Exomio, Model 1.1 (2002), cited by 1

## Recent decisions
- K181789: VeriSuite (Sep 21, 2018)
- K180308: Prelude (Mar 27, 2018)
- K170841: BiopSee, Mobile US (Jul 26, 2017)
- K163119: NaviSuite SSI Edition (May 1, 2017)
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle (Apr 3, 2014)
- K102237: PVS Model 1.0 (Nov 23, 2010)
- K100056: Medcom RT-Viewer System (May 7, 2010)
- K092653: Verisuite and Verisuite-Particle, Version 1.8 (Sep 18, 2009)

Source page: https://510kreport.com/company/medcom