RADIALIS PET IMAGER 0133

GUDID 00850031455337

The Radialis PET Imager (or Radialis PET Camera) 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.

Radialis Inc

PET system
Primary Device ID00850031455337
NIH Device Record Key937fc545-885f-4575-9634-319e43484f9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRADIALIS PET IMAGER
Version Model Number133
Catalog Number0133
Company DUNS203884668
Company NameRadialis Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com
Phone6138686157
Emailken.olsen@radialis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850031455337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

Devices Manufactured by Radialis Inc

00850031455337 - RADIALIS PET IMAGER2023-05-02The Radialis PET Imager (or Radialis PET Camera) 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.
00850031455337 - RADIALIS PET IMAGER2023-05-02 The Radialis PET Imager (or Radialis PET Camera) is a high spatial resolution, small field-of-view PET imaging camera specifical
08500314551332 - RADIALIS PET CAMERA2022-06-01 The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field-of-view PET imaging camera specifical

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