Submission Details
| 510(k) Number | K222596 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2022 |
| Decision Date | February 10, 2023 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
S90 Exp Series Digital Color Doppler Ultrasound System
Feb 2023
Decision
168d
Days
Class 2
Risk
About This 510(k) Submission
K222596 is an FDA 510(k) clearance for the S90 Exp 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 February 10, 2023, 168 days after receiving the submission on August 26, 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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