Cleared Abbreviated

NeuroLF (Basic) (K241751) - FDA 510(k) Clearance

Also marketed or referenced as:
NeuroLF (Pro) NeuroLF (Advanced) NeuroLF Seat

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K241751 · Positrigo AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
27d
Days
Class 2
Risk

K241751 is an FDA 510(k) clearance for the NeuroLF (Basic). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Positrigo AG (Zurich, CH). The FDA issued a Cleared decision on July 15, 2024 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Positrigo AG devices

Submission Details

510(k) Number K241751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2024
Decision Date July 15, 2024
Days to Decision 27 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 177
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K241751.
uMI Panvivo
K241596 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2024
Omni Legend
K241665 · Ge Medical Systems Israel, Functional Imaging · Aug 2024
Symbia SPECT and SPECT/CT Systems
K241898 · Siemens Healthineers · Jul 2024
SET-5002
K240827 · Shimadzu Corporation Medical Systems Division · May 2024
uEXPLORER
K231762 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2024
Biograph VK10
K233677 · Siemens Medical Solutions USA, Inc. · Jan 2024