WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K261916

510(k) cleared

NeuroQuant PET

Cortechs Labs, Inc. · Aug 12, 2026 · K261916

FDA cleared the NeuroQuant PET from Cortechs Labs, Inc. on Aug 12, 2026 under K261916, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 9, 2026. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cortechs Labs, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261916?

K261916 is the FDA 510(k) for NeuroQuant PET, submitted by Cortechs Labs, Inc.. FDA's decision date was Aug 12, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the NeuroQuant PET?

Cortechs Labs, Inc., based in San Diego, CA, is the applicant of record for K261916.

How long did the K261916 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Aug 12, 2026, 64 days later.

← All decisions in August 2026