ImagenSPECT

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes…

Registry build 21.09.26

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Beijing (1), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KPS
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

Regulatory record for ImagenSPECT
Listed by Cardiovascular Imaging Technologies L.L.C.
FDA product code KPS
Device type System, Tomography, Computed, Emission
Device class Class 2
Regulation 21 CFR 892.1200
510(k) K152503
Record published 2020-11-02
Record revised 2023-12-04 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for ImagenSPECT
Catalogue number Size Status
3.0 In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer