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Medcom GmbH

Also registered as Med.Com

Country not established FDA

Devices
12
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Medcom GmbH makes

Medcom GmbH manufactures medical imaging and visualization systems, including software suites like VeriSuite and NaviSuite SSI Edition for surgical navigation and intraoperative imaging. Their portfolio also includes standalone devices such as the EXOMIO (models 1.1 and 2.0 SP1) for intraoperative imaging, the MEDCOM RT-Viewer System for radiation therapy planning, and the Prelude for procedural guidance. BiopSee, Mobile US, appears to be a mobile imaging solution, while the PVS Model 1.0 supports intraoperative visualization.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States, and their products are listed in the FDA’s 510(k) registry.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

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  • Exomio, Model 1.1 Ref K022219

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medcom Rt-Viewer System Ref K100056

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • VeriSuite Ref K181789

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle Ref K133914

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • NaviSuite SSI Edition Ref K163119

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Verisuite And Verisuite-Particle, Version 1.8 Ref K092653

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aircare 300 Ref K830324

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • BiopSee, Mobile US Ref K170841

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pvs Model 1.0 Ref K102237

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Exomio, Model 2.0 SP1 Ref K032550

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Verisuite 1.6, Verisuite-Particle 1.6 Ref K080742

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Prelude Ref K180308

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-12 of 12

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Medcom GmbH Darmstadt Hesse · DE FEI 3006579682

Frequently asked questions

How many devices does Medcom GmbH have in the registry?

The registry currently lists 12 devices for Medcom GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medcom GmbH's devices?

Among its 12 most recently registered devices, Medcom GmbH has devices listed in FDA 510(k) (12 devices).

What risk classes do Medcom GmbH's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Medcom GmbH's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Medcom GmbH in the registry?

The most recently registered devices listed for Medcom GmbH include EXOMIO, MODEL 1.1, MEDCOM RT-VIEWER SYSTEM, VeriSuite and VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE.

Which FDA establishments are linked to Medcom GmbH?

1 FDA establishment is linked to Medcom GmbH in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.