The following data is part of a premarket notification filed by Qt Imaging, Inc. with the FDA for Qt Scanner 2000 Model A.
| Device ID | K220933 |
| 510k Number | K220933 |
| Device Name: | QT Scanner 2000 Model A |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | QT Imaging, Inc. 3 Hamilton Landing, Suite 160 Novato, CA 94949 |
| Contact | John Klock |
| Correspondent | John Klock QT Imaging, Inc. 3 Hamilton Landing, Suite 160 Novato, CA 94949 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-08-31 |