Radialis PET Camera
The Radialis PET Camera images the distribution of injected positron emitting radiopharmaceuticals in the body. The resulting images show relative tracer concentrations, providing…
The Radialis PET Camera images the distribution of injected positron emitting radiopharmaceuticals in the body. The resulting images show relative tracer concentrations, providing information about metabolic and physiological functions.
Lutetium containing gamma ray detectors collect radiation from the injected tracer. The camera converts these detected signals into PET images corresponding to the tracer’s distribution in the examined body region.
Listed Item
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.
Imaging Geometry
The camera uses a partial ring, planar detector arrangement with a small field of view. It is designed for close range imaging targeted to an organ or limited body region.
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Neusoft Positron Medical Systems Co., Ltd. | Shen Yang | Liaoning | Manufacturer | 1 |
Record
| Listed by | Radialis Inc., Canada |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K214062 |
| Record published | 2025-02-07 |
| Record revised | 2026-02-09 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0140 | Withdrawn | |
| 133 | Withdrawn |
Same Product Code
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| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| Discovery | GE Medical Systems, L.L.C. | 7 |
| uMI | Shanghai United Imaging Healthcare Co., Ltd. | 7 |
| Brightonix | Brightonix Imaging Inc. | 6 |
| UltraSPECT | Ultraspect USA, LLC | 5 |
| Discovery | G E Medical Systems Israel Ltd. | 5 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Encompass™ SRS Fibreplast™ System | Qfix | 4 |
| Veriton NM | Spectrum Dynamics Medical Ltd. | 3 |
| Cedars-Sinai Cardiac Suite | Cedars Sinai Medical Center | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K214062 | 2022-02-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.