UltraSPECT
WBR Imaging X + Bone/Xact + ACSC
4manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Ultraspect USA, LLC, United States |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Manufacturer |
| 510(k) | K103710 |
| Record published | 2026-07-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.0 | In distribution | |
| 4.38.3.3 | In distribution | |
| 4.38.3.3 | In distribution | |
| 4.38.3.3 | In distribution | |
| 4.38.3.3 | 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 |
| 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 |
| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
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.