Cleared Special

QT Scanner 2000 Model A

K253898 · QT Imaging Holdings, Inc. · Radiology

Mar 2026

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K253898 is an FDA 510(k) clearance for the QT Scanner 2000 Model A, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by QT Imaging Holdings, Inc. (Novato, US). The FDA issued a Cleared decision on March 4, 2026, 89 days after receiving the submission on December 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K253898 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2025
Decision Date	March 04, 2026
Days to Decision	89 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF