K261916

NeuroQuant PET

510(k) number
K261916
Device name
NeuroQuant PET
Applicant
Cortechs Labs, Inc. CA · US
Product code
LLZ — System, Image Processing, Radiological
Decision date
2026-08-12
Date received
2026-06-09
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K261916.pdf

Official FDA record: K261916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.