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Radialis, Inc.

CanadaFDA applicant, unverified

Radialis, Inc. is a medical device manufacturer, with 4 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.

Devices
4

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 3
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 4
Sites and related companies
Identifiers
  • DUNS 203884668

What Radialis, Inc. makes

Radialis, Inc. manufactures PET (Positron Emission Tomography) imaging systems, including dedicated PET cameras and imagers designed for medical diagnostics. These devices are used to capture detailed images of metabolic processes in the body, aiding in the detection and evaluation of conditions such as cancer, neurological disorders, and cardiovascular diseases.

The company’s PET systems are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) and UDI registries.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Radialis Pet Camera 133

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

  • Radialis Pet Camera 0140

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

  • Radialis Pet Imager 133

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

  • Radialis PET Camera Ref K214062

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

Company details

DUNS number
203884668
Phone
6138686157

Sites1

Frequently asked questions

How many devices does Radialis, Inc. have in the registry?

The registry currently lists 4 devices for Radialis, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Radialis, Inc.'s devices?

Among its 4 most recently registered devices, Radialis, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Radialis, Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Radialis, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Radialis, Inc. in the registry?

The most recently registered devices listed for Radialis, Inc. include RADIALIS PET CAMERA 133, RADIALIS PET CAMERA 0140, RADIALIS PET IMAGER 133 and Radialis PET Camera.

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