K163712 is an FDA 510(k) clearance for the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Shenzhen Wisonic Medical Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 2, 2018, 368 days after receiving the submission on December 30, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K163712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2016 |
| Decision Date | January 02, 2018 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| 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 |