QT Scanner 2000 Model A
QT Imaging, Inc.
QT Imaging, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011599810 | 3011599810 | QT Imaging, Inc. | 1 | N | 2026-01-01 | 3 Hamilton Landing Suite 160 Novato CA US 94949 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 212078 | 1608156377 | K220933 | QT Scanner 2000 Model A | IYO | 2022-08-31 |
| 212078 | 1146029410 | K162372 | QT Ultrasound Breast Scanner-1 | IYO | 2017-06-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYO | 2 | 2022-08-31 |
PMN#
GUDID#
QT Scanner 2000 - The QT Scanner 2000 Model B 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. The QT Scanner 2000 Model B is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
2026-06-24
QT Scanner 2000 - The QT Scanner 2000 Model A 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. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
2022-09-28