K202160 is an FDA 510(k) clearance for the Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on September 1, 2020, 29 days after receiving the submission on August 3, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K202160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2020 |
| Decision Date | September 01, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |