NeuroQuant PET— 510(k) K261916
Substantially EquivalentCortechs Labs, Inc.
FDA 510(k) clearance K261916 for NeuroQuant PET, Substantially Equivalent on 2026-08-12. Applicant: Cortechs Labs, Inc.. Device class: 2.
Summary
Cortechs Labs filed NeuroQuant PET under product code LLZ, radiological image processing systems. The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Cortechs filed from San Diego, California. Review took 64 calendar days (June 9 to August 12, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Cortechs Labs, Inc.
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LLZ
view allMore clearances from Cortechs Labs, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.