# K241751: NeuroLF  (Basic); NeuroLF  (Pro); NeuroLF  (Advanced); NeuroLF Seat

- Pathway: 510(k) (Abbreviated)
- Applicant: Positrigo AG
- Decided: Jul 15, 2024 after 27 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K091269 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210450: BBX-PET Scanner, Prescient Imaging, LLC (2021) Summary page 4.

## Indications for use
NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.

Source page: https://510kreport.com/device/K241751
Methodology: https://510kreport.com/methodology