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Imbio, LLC

Also registered as Imbio, Inc.

United StatesFDA applicant, unverified

Imbio, LLC is a medical device manufacturer, with 46 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.

Devices
46

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 40
  • FDA 510(k) 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 46
Identifiers
  • DUNS 078397649

What Imbio, LLC makes

Imbio, LLC develops software applications for processing and interpreting radiology images, including DICOM-compatible tools and X-ray analysis software. Their portfolio includes diagnostic aids for cardiac imaging, such as left ventricular function assessment, and automated image analysis for radiology workflows.

The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) clearances and UDI compliance.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue46

Newest first, rows 1-46 of 46

Search and filter all 46 devices
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  • Imbio Freya 5.0.0

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

  • Imbio LDA 2.4.1

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

  • Imbio LDA 5.0.2

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

  • Imbio LDA 2.5.2

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

  • Imbio LDA 3.0.2

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

  • Imbio LDA 2.7.1

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

  • Imbio Freya 4.0.1

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

  • Imbio LDA 3.0.0

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

  • Imbio RV/LV 3.0.0

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

  • Imbio LDA 5.1.1

    Listed Registry: GUDID Class:II

  • Imbio LDA 5.0.0

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

  • Imbio Freya 5.0.1

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

  • Imbio LDA 5.0.3

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

  • Imbio RV/LV 3.1.0

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

  • Imbio LDA 5.0.1

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

  • Imbio Freya 3.2.0

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

  • Imbio CAC 2.0.0

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

  • Imbio LDA 2.4.4

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

  • Imbio LDA 2.4.2

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

  • Imbio LDA 3.0.3

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

  • Imbio LDA 5.1.0

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

  • Imbio LDA 4.1.0

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

  • Imbio LDA 2.4.5

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

  • Imbio LDA 3.1

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

  • Imbio Freya 3.3.0

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

  • Imbio LDA 5.1.1

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

  • Imbio SET 1.0.3.3

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

  • Imbio LDA 2.4

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

  • Imbio LDA 2.4.3

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

  • Imbio RV/LV 3.1.1

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

  • Imbio PHA 4.0.0

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

  • Imbio RV/LV 2.0

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

  • Imbio LDA 2.5.1

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

  • Imbio SET 1.0.3.2

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

  • Imbio LDA 2.7.0

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

  • Imbio LDA 4.0.0

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

  • Imbio RV/LV 2.1

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

  • Imbio Freya 5.0.2

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

  • Imbio LDA 3.1.1

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

  • Imbio SET 1.0.3.5

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

  • Iq-Uip Ref K242467

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

  • Imbio PHA (4.0.0) Ref K241847

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

  • Lung Density Analysis Ref K141069

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

  • Imbio Segmentation Editing Tool software Ref K180129

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

  • CAC Software Ref K230112

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

  • Imbio RV/LV Software Ref K203256

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

Rows 1-46 of 46

Company details

DUNS number
078397649

Frequently asked questions

How many devices does Imbio, LLC have in the registry?

The registry currently lists 46 devices for Imbio, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Imbio, LLC's devices?

Among its 46 most recently registered devices, Imbio, LLC has devices listed in FDA 510(k) (6 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Imbio, LLC's devices fall under?

Among its 46 most recently registered devices, the classes recorded for Imbio, LLC's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Imbio, LLC in the registry?

The most recently registered devices listed for Imbio, LLC include Imbio Freya 5.0.0, Imbio LDA 2.4.1, Imbio LDA 5.0.2 and Imbio LDA 2.5.2.

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