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NeuroLF - NeuroLF (Pro)

by Positrigo AG

510(k) K241751

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241751↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK241751 Date15 Jul 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KPS
Models / Variants
NeuroLF (Pro)
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Other devices from Positrigo AG

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.