Data / Medical devices / United States / QT Imaging, Inc.
QT Imaging, Inc.: FDA-registered device maker in Novato, CA, United States, 1 510(k) clearance
QT Imaging, Inc. is registered with the FDA (registration 3011599810) in Novato, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 31, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011599810
- Address
- 3 Hamilton Landing Suite 160, Novato, CA, United States, 94949
- Owner or operator
- QT Imaging, Inc. (10055992)
- Roles
- Manufacturer
- First device listed
- February 20, 2025
- Registered through
- 2026
- Brand names listed
- Breast Acoustic CT, QT Scanner 2000 Model A, QT Scanner 2000 Model B, QTI Breast Retention Device, QTI Breast Retention Magnet Snap, QTviewer Image Viewing Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 31, 2022 | K220933 | QT Scanner 2000 Model A | IYO | Substantially Equivalent | Qt Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated August 31, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.