Thoracic VCAR with GSI Pulmonary Perfusion
by GE Medical Systems SCS France EUDAMED510(k)
510(k) K183210 Product code LLZ
Overview
The Thoracic VCAR with GSI Pulmonary Perfusion is a CT-based image analysis software package designed for non-invasive evaluation of thoracic structures. It integrates volumetric and perfusion analysis to assist in assessing pulmonary diseases, including quantitative lung volume measurements and perfusion visualization within the lungs.
This software is used in conjunction with CT lung imaging and supports Gemstone Spectral Imaging (GSI) acquisitions. Supplied as a digital product, it requires compatible CT imaging equipment for operation. Authorized under FDA 510(k) clearance (K183210) and MDR, it is intended for clinical use in radiology settings. No sterility or single-use considerations apply, as it is a reusable software tool.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK183210 | Date29 Mar 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from GE Medical Systems SCS
Questions
What clinical assessments can the Thoracic VCAR with GSI Pulmonary Perfusion software help with during a CT scan?
The Thoracic VCAR with GSI Pulmonary Perfusion software is designed to assist in evaluating pulmonary diseases through non-invasive CT-based analysis. It provides volumetric measurements of lung tissue and visualizes perfusion within the lungs, which can help clinicians assess conditions like lung volume abnormalities or perfusion defects. The integration with Gemstone Spectral Imaging (GSI) acquisitions further enhances its ability to analyze lung structures in detail.
How is this software supplied, and what equipment does it require to operate?
The Thoracic VCAR with GSI Pulmonary Perfusion is supplied as a digital software package, meaning it is not a physical device but rather a tool installed on compatible systems. To operate, it requires integration with CT imaging equipment capable of performing lung scans, particularly those supporting Gemstone Spectral Imaging (GSI) acquisitions. No additional hardware is needed beyond the CT scanner and a compatible computing environment.
Is this software reusable, or does it have any sterility or single-use requirements?
Since the Thoracic VCAR with GSI Pulmonary Perfusion is a software-based tool, it is designed for reusable clinical use across multiple patients. Unlike physical medical devices, it does not require sterilization or adhere to single-use guidelines. However, the underlying CT imaging equipment used in conjunction with the software may have its own operational and maintenance protocols.
What regulatory pathways does this software follow, and where is it authorized for use?
The Thoracic VCAR with GSI Pulmonary Perfusion has been authorized through the FDA’s 510(k) clearance process (K183210) and meets EU requirements under the Medical Device Regulation (MDR). These pathways confirm its compliance for clinical use in radiology settings in the United States and the European Economic Area, respectively. No additional approvals or certifications are mentioned beyond these regulatory clearances.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K183210
- EUDAMED