K180461 is an FDA 510(k) clearance for the Navi e/Navi s/Navi X 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 May 9, 2018, 78 days after receiving the submission on February 20, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K180461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2018 |
| Decision Date | May 09, 2018 |
| Days to Decision | 78 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 |