RADIALIS PET CAMERA

GUDID 00850031455016

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.

Radialis Inc

PET system

• Primary Device ID: 00850031455016
• NIH Device Record Key: f7cad2ef-0491-4af5-9f6e-a3002734524c
• Commercial Distribution Discontinuation: 2025-02-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RADIALIS PET CAMERA
• Version Model Number: 0140
• Company DUNS: 203884668
• Company Name: Radialis Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031455016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214062

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [RADIALIS PET CAMERA]

• 08500314551332: The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field-of-vi
• 00850031455016: The Radialis PET Camera (or Radialis PET Imager) is a high spatial resolution, small field-of-vi