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 / March 2026 / K253898

510(k) cleared

QT Scanner 2000 Model A

QT Imaging Holdings, Inc. · Mar 4, 2026 · K253898

FDA cleared the QT Scanner 2000 Model A from QT Imaging Holdings, Inc. on Mar 4, 2026 under K253898, a special 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 5, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

QT Imaging Holdings, Inc. has one other decision in the tracker over the last 12 months: K261535 (Hi-D Imaging 4TAVR).

Questions & Answers

What did FDA clear under K253898?

K253898 is the FDA 510(k) for QT Scanner 2000 Model A, submitted by QT Imaging Holdings, Inc.. FDA's decision date was Mar 4, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the QT Scanner 2000 Model A?

QT Imaging Holdings, Inc., based in Novato, CA, is the applicant of record for K253898.

How long did the K253898 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Mar 4, 2026, 89 days later.

← All decisions in March 2026

Sources