NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat— 510(k) K241751

Name: FDA 510(k) clearance K241751
Creator: U.S. Food and Drug Administration
Published: 2024-07-15

Substantially Equivalent

Positrigo AG

FDA 510(k) clearance K241751 for NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat, Substantially Equivalent on 2024-07-15. Applicant: Positrigo AG. Device class: 2.

Clearance details

Applicant: Positrigo AG
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2024-06-18
Decision date: 2024-07-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.