K190314 is an FDA 510(k) clearance for the Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Mednovel Technology, Ltd. (Milpitas, US). The FDA issued a Cleared decision on October 9, 2019, 238 days after receiving the submission on February 13, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K190314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2019 |
| Decision Date | October 09, 2019 |
| Days to Decision | 238 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 |