K192107 is an FDA 510(k) clearance for the Clarius Ultrasound Scanner. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Clarius Mobile Health Corp. (Burnaby, CA). The FDA issued a Cleared decision on August 29, 2019, 24 days after receiving the submission on August 5, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K192107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 24 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |