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Eigen

Also registered as Eigen, LLC

United Statesfrom the FDA registration address FDA FEI 2937707

Devices
18
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Eigen makes

Eigen manufactures digital imaging and archiving systems for medical diagnostics, including digital fluoroscopy storage solutions, digital disk recorders with archive capabilities, and digital photospot devices. Their portfolio also includes cardiac monitoring systems like the HR-2000 series with loop and digital recording functions, as well as digital subtraction angiography (DSA) systems for vascular imaging. Additional products cover electrocardiogram (ECG) recording devices with numerical suffixes and specialized imaging tools like the ProFuse CAD system for coronary artery analysis.

Eigen’s devices are classified under FDA’s Class I and Class II categories, with many authorised through the 510(k) premarket notification process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with US regulatory requirements. The company operates from the United States, adhering to domestic medical device regulations.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

Newest first, rows 1-18 of 18

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  • Hr-2000 W/Suffixes B, C, D, Cardio & Digi Loop, Ddvp Ref K882175

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

  • Digital Photospot Ref K902927

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

  • Vtr-12 Ref K882176

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

  • ProFuse CAD Ref K173744

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

  • Artemis Ref K162474

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

  • Digital Disk Recorder W/Dualpath Archive/30-60 Opt Ref K924164

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

  • Digital Fluoro Store Ref K923585

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

  • Digital Disk Recorder Ref K933115

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

  • Dsa 2000EX Ref K082341

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

  • 3-D Imaging Workstation Ref K081093

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

  • Eigen Dsa 2000 Ref K063846

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

  • Digital Fluoro Store(Dfs) W/Numerical Suffixes Ref K913012

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

  • Artemis, Artemis TPO, Artemis MX Ref K222222

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

  • Digital 8 W/Other Numerical Suffixes (1-9, Etc.) Ref K901956

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

  • Digital Disk Recorder(Ddr) W/Numerical Suffixes Ref K905111

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

  • Sc-1000 With Suffixes (Scan Converter) Ref K890745

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

  • Psc-1 W/Other Numerical Ref K903821

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

  • Hr-1000 W/Suffixes (B, C Or D) Ref K882184

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

Rows 1-18 of 18

Company details

FDA FEI number
2937707
Address
13366 Grass Valley Ave, Suite A, Grass Valley, CA, 95945

Frequently asked questions

How many devices does Eigen have in the registry?

The registry currently lists 18 devices for Eigen. Devices recorded under merged duplicate company entries are counted once.

Which registries list Eigen's devices?

Among its 18 most recently registered devices, Eigen has devices listed in FDA 510(k) (18 devices).

What risk classes do Eigen's devices fall under?

Among its 18 most recently registered devices, the classes recorded for Eigen's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Eigen in the registry?

The most recently registered devices listed for Eigen include HR-2000 W/SUFFIXES B, C, D, CARDIO & DIGI LOOP, DDVP, DIGITAL PHOTOSPOT, VTR-12 and ProFuse CAD.

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