QT Scanner 2000 Model A

FDA 510(k) K253898 · QT Imaging Holdings, Inc.

Substantially Equivalent

510(k) numberK253898

Submission

Device name
QT Scanner 2000 Model A
Applicant
QT Imaging Holdings, Inc.
Novato, CA, US
Received
December 5, 2025
Decision date
March 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was QT Scanner 2000 Model A cleared by the FDA?

QT Scanner 2000 Model A (K253898) received a 510(k) decision of Substantially Equivalent on March 4, 2026, 89 days after the submission was received.

What is the product code of K253898?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.