FastStroke CT Perfusion 4D
by GE Medical Systems SCS France EUDAMED510(k)
510(k) K193289 Product code JAK
Overview
The FastStroke CT Perfusion 4D is a CT Perfusion Imaging Device designed to assess cerebral blood flow, volume, and permeability in acute stroke patients. It provides dynamic 4D perfusion mapping to evaluate ischemic tissue and guide treatment decisions, supporting rapid diagnosis and intervention in emergency settings.
This device is supplied as a software application integrated with CT scanners, requiring no additional sterility measures beyond standard imaging protocols. It operates in radiology departments and is intended for single-use per imaging session, with no reusable components. The system adheres to MRI safety standards for CT environments and is authorised under FDA 510K clearance and MDR compliance, ensuring regulatory adherence for clinical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK193289 | Date12 Nov 2020 | 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- Withdrawn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
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from GE Medical Systems SCS
Questions
What clinical scenarios is the FastStroke, CT Perfusion 4D specifically designed to support in emergency care?
The FastStroke, CT Perfusion 4D is designed to assess cerebral blood flow, volume, and permeability in acute stroke patients to evaluate ischemic tissue. Its dynamic 4D perfusion mapping helps clinicians rapidly diagnose stroke severity and guide treatment decisions, such as thrombolysis or thrombectomy, in emergency settings.
Is the FastStroke, CT Perfusion 4D a standalone device, or does it require integration with another system?
The FastStroke, CT Perfusion 4D is a software application that integrates with CT scanners. It does not require additional hardware or sterility measures beyond standard imaging protocols, making it a seamless addition to existing CT workflows in radiology departments.
How is the FastStroke, CT Perfusion 4D intended to be used in a clinical setting, and are there any reusable components?
The device is intended for single-use per imaging session, with no reusable components. It operates within radiology departments where CT scanners are already in use, ensuring no additional sterility or maintenance requirements beyond standard imaging practices.
What regulatory pathways does the FastStroke, CT Perfusion 4D follow, and how does this affect its clinical deployment?
The device is authorized under FDA 510K clearance and MDR compliance, confirming its regulatory adherence for clinical use. The FDA’s Radiology (RA) advisory committee reviewed it as substantially equivalent (SESE) to a predicate device, ensuring it meets safety and performance standards before deployment in hospitals.
Does the FastStroke, CT Perfusion 4D have any special safety considerations related to its operating environment?
Yes, the system adheres to MRI safety standards for CT environments, meaning it is designed to operate safely alongside CT scanners while maintaining compatibility with radiology department protocols. This ensures minimal additional risk or operational changes for clinicians.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K193289
- EUDAMED