Veriton CT
VERITON CT combines single photon emission computed tomography with X-ray CT imaging. The SPECT component maps radiopharmaceutical distribution to show physiological activity, while CT…
VERITON CT combines single photon emission computed tomography with X-ray CT imaging. The SPECT component maps radiopharmaceutical distribution to show physiological activity, while CT provides anatomical cross sections for locating that activity.
The two scanners can work together or independently. Combined examinations register the physiological and anatomical images, and CT images can provide attenuation correction for the SPECT data.
Listed Item
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
Model Configurations
The 300 and 400 series include 16 and 64 slice CT configurations. Their SPECT energy ranges extend respectively to 300 or 400 keV, depending on the model. Trained healthcare professionals use the system for evaluating disease and organ function and for planning or monitoring treatment.
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 | Spectrum Dynamics Medical Ltd., Israel |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K230600 |
| Record published | 2023-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VERITON CT 316 | In distribution | |
| VERITON CT 364 | In distribution | |
| VERITON CT 464 | In distribution | |
| VERITON CT 16 | In distribution | |
| VERITON CT 416 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254001 | 2026-01-13 |
| K230600 | 2023-04-28 |
| K190457 | 2019-07-12 |
| K182484 | 2018-11-09 |
| K180514 | 2018-04-25 |
| K161740 | 2016-11-04 |
| K160120 | 2016-03-21 |
| K072468 | 2007-10-01 |
| K062450 | 2006-10-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-07-15 | Not classified | Nonconforming Material/Component | The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically, it was reported that if the detector housing securing mechanism is compromised, the detector housing may pull away from its secured po | Domestic- 35 units, Foreign – 7 units | 2015-04-01 |
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.