QT Scanner 2000 Model A
by QT Imaging Holdings, Inc. 510(k)
Active
510(k) K253898
Overview
The QT Scanner 2000 Model A is an ultrasonic imaging system designed to provide reflection-mode and transmission-mode images of a patient's breast. It is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator.
The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. It has received FDA 510(k) clearance under submission K253898, with a final decision date of 2026-03-04, and is listed in the FDA's Artificial Intelligence-Enabled Medical Devices list.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253898 | Date4 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the QT Scanner 2000 Model A used for?
The QT Scanner 2000 Model A is designed to provide reflection-mode and transmission-mode ultrasonic images of a patient's breast, enabling breast imaging through an automated, software-controlled system operated by a single user.
How is the QT Scanner 2000 Model A supplied and what components does it include?
The system is supplied as a complete unit consisting of an examination table, a scan tank, image processing electronics, an operator console, a breast retention device, and ultrasound beam forming electronics, all integrated for automated breast imaging.
Is the QT Scanner 2000 Model A intended for single-use or reusable operation?
The QT Scanner 2000 Model A is a reusable ultrasonic imaging system designed for repeated clinical use; it is not a single-use device and requires standard cleaning and maintenance between patient examinations as per manufacturer guidelines.