NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
by Positrigo AG EUDAMED510(k)
Active
510(k) K241751
Overview
The NeuroLF is a small-aperture Positron Emission Tomography (PET) scanner designed for high-resolution imaging of the head and neck. It features an octagonal detector ring with 384 LYSO crystals to capture functional metabolic data, enabling precise evaluation of neurological and oncological conditions in these regions. The system is classified as a Computed Tomography, Emission, System under regulatory categorization.
The NeuroLF is supplied as a modular system, including Basic, Pro, Advanced, and Seat configurations, tailored for clinical radiology settings. Each variant is intended for single-use or reusable components as specified by the manufacturer, with sterility maintained per regulatory standards. The device operates in MRI-unsafe environments and is authorized under FDA 510(k) clearance and MDR compliance, with a Class II designation. Storage and handling follow manufacturer guidelines to preserve imaging accuracy and patient positioning integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK241751 | Date15 Jul 2024 | 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- Withdrawn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
- KPS
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Positrigo AG
Questions
What clinical areas is the NeuroLF primarily designed to support with its imaging capabilities?
The NeuroLF is specifically engineered for high-resolution imaging of the head and neck regions, making it particularly useful for evaluating neurological and oncological conditions in these areas. Its small-aperture PET design allows for detailed metabolic data capture, which aids in diagnosing and monitoring brain tumors, neurological disorders, and other pathologies affecting these critical areas.
How are the different NeuroLF configurations (Basic, Pro, Advanced, Seat) distinguished, and what does this modularity mean for clinical workflows?
The NeuroLF is offered in four modular configurations—Basic, Pro, Advanced, and Seat—each tailored to different clinical needs and settings. While the exact differences between these variants aren’t detailed in specifications, the modularity suggests flexibility in adapting the system to varying workflows, such as standalone imaging (Basic), expanded functionality (Pro/Advanced), or specialized applications like patient positioning (Seat). This allows facilities to scale the system based on their specific diagnostic requirements.
Are the components of the NeuroLF designed for single-use or reusable applications, and how does sterility factor into its use?
The NeuroLF system includes components that can be either single-use or reusable, as specified by the manufacturer. Sterility is maintained per regulatory standards, ensuring safe use whether components are discarded after a single use or reprocessed for reuse. This flexibility accommodates different clinical protocols and infection control policies, though proper handling and maintenance are critical to preserving imaging accuracy and patient safety.
What environmental considerations should be taken into account when operating the NeuroLF, particularly regarding MRI compatibility?
The NeuroLF is explicitly designed for use in MRI-unsafe environments, meaning it should not be operated near MRI machines or in areas where magnetic interference could pose a risk. Clinicians must ensure the device is placed in a location free from MRI equipment to avoid potential hazards to both patients and staff. This distinction is important for facilities with integrated imaging suites.
What regulatory pathways have been followed for the NeuroLF, and how does this affect its adoption in clinical settings?
The NeuroLF has undergone FDA 510(k) clearance and MDR compliance, with a Class II designation under regulatory categorization. This means it has been evaluated for substantial equivalence to existing devices and meets European safety and performance standards. Clinicians and procurement teams can rely on these pathways to confirm the device’s regulatory standing, though local compliance requirements should always be verified before adoption.