D-Spect Refurbished
The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional…
The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data.
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) | K161740 |
| Record published | 2026-02-09 |
| Record revised | 2020-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 30 to 70 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D-SPECT 002 | In distribution | |
| 002 | In distribution | |
| D-SPECT 004 | 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 |
| 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 |
|---|---|
| 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.