Submission Details
| 510(k) Number | K221140 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 19, 2022 |
| Decision Date | September 13, 2022 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
P20 Elite Series Digital Color Doppler Ultrasound System
Sep 2022
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K221140 is an FDA 510(k) clearance for the P20 Elite Series Digital Color Doppler Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on September 13, 2022, 147 days after receiving the submission on April 19, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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