Radialis Inc

Address:290 Munro Street,Thunder Bay Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Tomography, Computed, Emission (KPS) (1)

Premarket Exempt

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RADIALIS PET CAMERA - 08500314551332 Catalog Number : 0133

Device Description : The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, s The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Camera is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Camera is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient’s body part with high efficiency.

Device Class : 2

Duns Number: 203884668

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

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