K190646 is an FDA 510(k) clearance for the QT Scanner 2000 Model A. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Qt Ultrasound, LLC (Novato, US). The FDA issued a Cleared decision on October 18, 2019, 219 days after receiving the submission on March 13, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K190646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |