Veriton NM
VERITON NM is a nuclear medicine imaging system that detects the distribution of radioisotope tracers in the body. It reconstructs the acquired data into cross-sectional images using single…
VERITON NM is a nuclear medicine imaging system that detects the distribution of radioisotope tracers in the body. It reconstructs the acquired data into cross-sectional images using single photon emission computed tomography.
The system supports whole body and tomographic imaging, with static, dynamic and physiologically gated acquisitions. It can acquire single-isotope or multiple-isotope studies and use automatic body contouring during imaging.
Listed Item
Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
Image Assessment
Software supports image display, processing, analysis and uptake quantification. Trained healthcare professionals use the images to evaluate disease and organ function and to support treatment planning or monitoring. The system is intended for patients of all ages.
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) | K180514 |
| Record published | 2018-11-08 |
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 |
|---|---|---|
| 001 | In distribution | |
| 400 | In distribution | |
| 300 | 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 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Encompass™ SRS Fibreplast™ System | Qfix | 4 |
| 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.